Clinical Report for Milky Soft Mineral Based Sunscreen for Babies
Milky Soft Mineral Based Sunscreen for Babies: Clinical Efficacy Report
Independently tested at CCFT Laboratories with in-vivo SPF 51.238, PA+++ (in vitro), 377 nm critical wavelength and 3-star Boots rating - broad-spectrum protection from a 100% mineral-filter sunscreen made for babies. Registered with the Clinical Trials Registry - India under CTRI/2026/03/105486.
At a Glance: Sunscreen Performance Metrics
Sunscreen Efficacy Certificate - CCFT Laboratories Pvt. Ltd., CTRI/2026/03/105486, signed by Puneet Mittal, Director R&D.
Sunscreen Efficacy Certificate - CCFT Laboratories Pvt. Ltd., CTRI/2026/03/105486, sample AP5F095. If the certificate does not display in your browser, use the View Certificate PDF button above.
| In-Vivo SPF | PA Rating (In-Vitro) | Critical Wavelength | Boots Star | Broad Spectrum |
|---|---|---|---|---|
| 51.238 | +++ | 377 nm | *** | Yes |
This product was evaluated for sunscreen efficacy at CCFT Laboratories Pvt. Ltd. on sample AP5F095 under CTRI/2026/03/105486, in accordance with IS 17494:2025 (ISO 24444:2019, MOD) and the COLIPA in-vitro guideline.
1. Study Overview & Design
| Study Parameter | Detail |
|---|---|
| Study Title | Sunscreen Efficacy Certificate for Milky Soft Mineral Based Sunscreen for Babies |
| Specific Parameters Measured | Sun Protection Factor (SPF) - In-vivo; PA Rating, Critical Wavelength, Boots Star Rating and Broad Spectrum Classification - In-vitro |
| Why These Parameters Matter | Baby skin has a thinner stratum corneum and less melanin than adult skin, so it burns faster and sun damage accumulates earlier. UVB (290-320 nm) causes sunburn; UVA (320-400 nm) penetrates deeper. A baby sunscreen needs verified protection across both, which is what in-vivo SPF plus in-vitro UVA metrics establish. |
| Study Type | In-vivo SPF evaluation on human volunteers, plus in-vitro spectral evaluation |
| Testing Methods | IS 17494:2025 (ISO 24444:2019, MOD) - In-vivo SPF; COLIPA Guideline - In-vitro PA, critical wavelength, Boots Star, broad spectrum |
| Specific Product Studied | Milky Soft Mineral Based Sunscreen for Babies - sample AP5F095 (commercial formulation) |
| CTRI Registration | CTRI/2026/03/105486 - searchable at ctri.nic.in |
| Product Connection | A mineral-filter baby sunscreen built on Zinc Oxide and Titanium Dioxide, with Oats, Milk and Calendula in a lightweight, water-resistant base - dermatologically tested and Made Safe certified, free of silicones, parabens, mineral oil and dyes. The pack is labelled SPF 30 PA+++. |
2. Claim Substantiation Matrix
| Claim | Certificate | Evidence | Status |
|---|---|---|---|
| SPF 30 | Sunscreen Efficacy Certificate | In-vivo SPF 51.238 - IS 17494:2025 (ISO 24444:2019, MOD). Measured value exceeds the on-pack label. | Supported |
| PA+++ | Sunscreen Efficacy Certificate | PA+++ (in vitro) - COLIPA Guideline. Matches the on-pack label. | Supported |
| Broad Spectrum | Sunscreen Efficacy Certificate | Critical wavelength 377 nm exceeds the 370 nm threshold | Supported |
| Boots Star *** | Sunscreen Efficacy Certificate | *** - UVA/UVB absorbance ratio 60-80% (Boots method) | Supported |
| In-Vivo Tested | Sunscreen Efficacy Certificate | SPF measured on human volunteers | Supported |
| CTRI Registered | Clinical Trials Registry - India | CTRI/2026/03/105486 | Verified |
| Mineral-based, water-resistant, Made Safe certified, dermatologically tested | Product page | Formulation and brand claims; dermatological tolerance is covered by the separate patch test certificate. Not part of the efficacy study. | Brand claim |
3. Test Results and Clinical Interpretation
3.1 Laboratory Results
| Outcome | Result | Method | Clinical Classification |
|---|---|---|---|
| SPF (In-Vivo) | 51.238 | IS 17494:2025 (ISO 24444:2019, MOD) | High protection - exceeds the SPF 30 on-pack label |
| PA Rating (In-Vitro) | +++ | COLIPA Guideline | High UVA protection (UVA-PF 8 to less than 16) |
| Critical Wavelength | 377 nm | COLIPA Guideline | Exceeds the 370 nm threshold - broad spectrum |
| Boots Star Rating | *** | COLIPA / Boots method | 60-80% UVA/UVB absorbance ratio |
| Broad Spectrum | Yes | COLIPA Guideline | Protection verified across UVB (290-320 nm) and UVA (320-400 nm) |
3.2 Clinical Interpretation of Results
| Metric | Interpretation |
|---|---|
| SPF 51.238 (In-Vivo) | Under standardised conditions per IS 17494:2025, the product demonstrated roughly 51 times more protection against UVB-induced erythema than unprotected skin. The pack is labelled SPF 30; the measured value is well above that label, so the claim is supported with margin (Diffey, 2001, PMID: 11348430). |
| PA+++ (In-Vitro) | PA+++ corresponds to a UVA Protection Factor of 8 to less than 16 on the Protection Grade of UVA scale used across India, Japan, South Korea and Southeast Asia - high, one tier below the PA++++ maximum (Wang et al., 2011, PMID: 21463374). |
| Critical Wavelength 377 nm | Critical wavelength is the point where 90% of total UV absorbance occurs. Exceeding 370 nm confirms coverage into the UVA-I range (340-400 nm) and supports the broad-spectrum classification (Wang et al., 2011, PMID: 21463374). |
| Boots Star Rating *** | The Boots Star Rating measures the ratio of UVA to UVB protection. Three stars indicates a 60-80% ratio (Diffey, 2011, PMID: 21564299). The certificate summarises this as "effective protection against UVB rays while offering a degree of protection against UVA rays". |
| Broad Spectrum | Broad spectrum classification confirms meaningful protection across both UVB and UVA wavelengths; a critical wavelength of at least 370 nm is required (Wang et al., 2011, PMID: 21463374). |
Original Laboratory Reports
The certificate supporting the sunscreen efficacy results is available below, as issued by CCFT Laboratories.
Sunscreen Efficacy Certificate
The Sunscreen Efficacy Certificate for Milky Soft Mineral Based Sunscreen for Babies (AP5F095) is available as issued by CCFT Laboratories. It states the in-vivo SPF, in-vitro PA rating, critical wavelength, Boots star rating, broad-spectrum status and CTRI registration number, signed by Puneet Mittal, Director R&D.
4. Formulation Architecture & UV Filter System
Milky Soft Mineral Based Sunscreen for Babies was tested as the commercial formulation. The protection comes from mineral UV filters (Zinc Oxide and Titanium Dioxide) in a nourishing base of Oats, Milk, Calendula and plant butters.
4.1 UV Filter System
| Formulation System | Key Components | Function & Performance Rationale |
|---|---|---|
| Mineral UV Filter System | Zinc Oxide, Titanium Dioxide | Zinc oxide is a broad-spectrum inorganic filter covering UVB through UVA-I; titanium dioxide adds UVB and short-UVA absorption. Both sit on the skin surface, are photostable and are the filters paediatric guidance generally prefers for babies (Smijs & Pavel, 2011, PMID: 22046105). |
| Emollient Base | Olive oil esters (Ethyl Olivate, Olive Oil Methyl Ester), Coconut Oil, Cocoa Butter, Shea Butter, Sweet Almond Oil | Disperse the mineral particles evenly and leave the skin soft; shea and cocoa butters add the 'milky soft' after-feel. |
4.2 Skin Care & Sensory Profile
| Attribute | Basis | Rationale |
|---|---|---|
| Oats, Milk & Calendula | Product page | Oats (colloidal) and calendula soothe; milk proteins condition. The brand's signature trio for the Milky Soft baby range. |
| Water-resistant | Product page | Lightweight, water-resistant texture for bath-time and pool days; reapply after water regardless. |
| Dermatologically tested & Made Safe certified | Product page | Skin tolerance is assessed in the separate patch test certificate; Made Safe screens the formula against a list of known toxins. |
4.3 Exclusion Profile: What is Not in This Formula
| What is absent | Why it matters |
|---|---|
| No organic (chemical) UV filters | Protection is 100% mineral - no avobenzone, octinoxate or oxybenzone, which removes the photostability and sensitisation concerns associated with some organic filters on infant skin. |
| No silicones, parabens, mineral oil or dyes | Brand claim on the product page, consistent with the published INCI. |
5. Published Research Supporting Key Ingredients
5.1 UV Filters and Photoprotection
| Ingredient | Primary Published Finding | Study Reference |
|---|---|---|
| Zinc Oxide | Broad-spectrum inorganic UV filter covering UVB and UVA including UVA-I; photostable and well tolerated | Smijs & Pavel, 2011, PMID: 22046105 |
| Titanium Dioxide | Inorganic filter with strong UVB and short-UVA attenuation; photostable | Smijs & Pavel, 2011, PMID: 22046105 |
| UVA/UVB balance | The Boots Star system quantifies the ratio of UVA to UVB protection | Diffey, 2011, PMID: 21564299 |
5.2 Infant Skin & Sun Protection
| Topic | Primary Published Finding | Study Reference |
|---|---|---|
| Infant skin barrier | Infant skin differs structurally from adult skin and continues maturing through the first years of life | Stamatas et al., 2011, PMID: 20807257 |
| Sun protection in infancy | Guidance recommends shade and clothing for infants under six months, with broad-spectrum sunscreen on exposed skin from six months onward | Paller et al., 2011, PMID: 21504412 |
| Broad-spectrum criteria | Critical wavelength of at least 370 nm is the accepted threshold for broad-spectrum labelling | Wang et al., 2011, PMID: 21463374 |
6. Frequently Asked Questions
Q: What does the in-vivo SPF of 51.238 mean in practical terms?
A: Under IS 17494:2025 (ISO 24444:2019), an in-vivo SPF of 51.238 means the sunscreen provided roughly 51 times more protection against UVB-induced erythema than unprotected skin on the test panel. The pack is labelled SPF 30, which this measured value comfortably supports (Diffey, 2001, PMID: 11348430).
Q: What does PA+++ mean?
A: PA+++ is the third tier of the Protection Grade of UVA system used across India, Japan, South Korea and Southeast Asia, corresponding to a UVA Protection Factor of 8 to less than 16 - high UVA protection. PA++++ (16 or above) is the top tier. On this certificate the PA rating was measured in vitro (Wang et al., 2011, PMID: 21463374).
Q: What does a critical wavelength of 377 nm mean?
A: Critical wavelength is the point where 90% of a sunscreen's total UV absorbance occurs. 377 nm clears the 370 nm international threshold for broad-spectrum classification, confirming coverage into the UVA-I range (Wang et al., 2011, PMID: 21463374).
Q: Why does the certificate say 'a degree of protection' against UVA?
A: That is the certificate's own wording, reflecting the Boots *** rating (60-80% UVA/UVB absorbance ratio) and the PA+++ tier. The product is broad spectrum, but its UVA protection is one tier below the PA++++ maximum - typical of mineral-filter baby sunscreens, which prioritise tolerance over the very highest UVA ratios.
Q: From what age can I use this on my baby?
A: Paediatric guidance recommends shade, clothing and hats for babies under six months, with sunscreen on exposed skin from six months onward. For a younger baby or one with eczema or very reactive skin, ask your paediatrician first (Paller et al., 2011, PMID: 21504412).
Q: How much should I apply, and how often?
A: Enough to leave a visible layer - roughly a 5-rupee-coin amount for a baby's face and neck - 15 minutes before sun exposure. Reapply every 2 hours, and after swimming, sweating or towel-drying. The SPF result reflects the ISO application rate of 2 mg/cm²; a thin layer gives much less protection.
Q: How can I verify this study myself?
A: The study is registered with the Clinical Trials Registry - India under CTRI/2026/03/105486, which you can search at ctri.nic.in independently of the brand. The original certificate is linked on this page.
Q: The pack says SPF 30 but the lab measured 51 - which is right?
A: Both. SPF labelling is a claim the measured value must support; the laboratory recorded an in-vivo SPF of 51.238, comfortably above the SPF 30 printed on the pack. The brand has chosen a conservative label; the certificate shows the formula performs well beyond it.
Q: Does a mineral sunscreen leave a white cast on my baby?
A: Zinc oxide and titanium dioxide can leave a slight whiteness, which is the trade-off for a mineral-only formula. A thin, even layer that is rubbed in for a minute minimises it; the whiteness also fades as the oils absorb.
7. Laboratory References and Certificate Details
| Field | Detail |
|---|---|
| Testing Laboratory | CCFT Laboratories Pvt. Ltd., Meerut (Centre for Cruelty-Free Testing, Mittal Global Clinical Trial Services) |
| Lab Certifications | ISO 9001:2015, ISO 45001:2015, OECD GLP Compliant |
| Lab Classification | FIST Centre - Dept. of Science & Technology, Govt. of India |
| CTRI Registration No. | CTRI/2026/03/105486 - verifiable at ctri.nic.in |
| Sample / Batch Code | AP5F095 |
| Date of Issue | Not printed on this certificate |
| In-Vivo SPF Method | IS 17494:2025 (ISO 24444:2019, MOD) |
| In-Vitro Method | COLIPA Guideline |
| Certificate | Sunscreen Efficacy Certificate |
| Sponsor / Brand Owner | Mamaearth (Honasa Consumer Ltd) |
| Signed By | Puneet Mittal, Director R&D, CCFT Laboratories Pvt. Ltd. |
All results reflect testing on the product formulation as commercially available. Results are test-specific under controlled laboratory conditions at the ISO application rate of 2 mg/cm². Real-world outcomes may vary. Reapplication as directed on product packaging is recommended.
8. References
- Diffey BL. Sunscreen isn't enough. J Photochem Photobiol B. 2001;64(2-3):105-108. PMID: 11348430
- Wang SQ, Balagula Y, Osterwalder U. Photoprotection: A review of the current and future technologies. Dermatol Ther. 2011;24(1):31-47. PMID: 21463374
- Diffey BL. The Boots Star Rating system for sunscreen products. Photodermatol Photoimmunol Photomed. 2011;27(3):159-160. PMID: 21564299
- Smijs TG, Pavel S. Titanium dioxide and zinc oxide nanoparticles in sunscreens: focus on their safety and effectiveness. Nanotechnol Sci Appl. 2011;4:95-112. PMID: 22046105
- Stamatas GN, Nikolovski J, Mack MC, Kollias N. Infant skin physiology and development during the first years of life. Int J Cosmet Sci. 2011;33(1):17-24. PMID: 20807257
- Paller AS, Hawk JL, Honig P, et al. New insights about infant and toddler skin: implications for sun protection. Pediatrics. 2011;128(1):92-102. PMID: 21504412
- Bureau of Indian Standards. IS 17494:2025 Cosmetics - Sun protection test methods - In vivo determination of the sun protection factor (SPF). BIS; 2025.
- COLIPA. Method for the in vitro determination of UVA protection provided by sunscreen products. COLIPA; 2011.
- CCFT Laboratories Pvt. Ltd. Sunscreen Efficacy Certificate for ME Milky Soft Mineral Based Sunscreen for Babies (AP5F095). CTRI/2026/03/105486. CCFT Laboratories; 2026.
