FDA.reportPublic FDA data

La Roche Posay Laboratoire Dermatologique Anthelios 60 Melt In Sunscreen Milk Broad Spectrum SPF 60 Face and Body

Product NDC
49967-003
11-digit product format
499670003
Labeler code
49967
Product ID
49967-003_0a19a27a-23ef-4072-8e73-d262d50ea95d
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene and Oxybenzone
Dosage form
LOTION
Route
TOPICAL
Labeler
L'Oreal USA Products Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-06-01
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Active strength
30; 107.2; 32.1; 60; 38.6 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
La Roche Posay Laboratoire Dermatologique Anthelios 60 Melt In Sunscreen Milk Broad Spectrum SPF 60 Face and Body
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/mL
HOMOSALATE107.2 mg/mL
OCTISALATE32.1 mg/mL
OCTOCRYLENE60 mg/mL
OXYBENZONE38.6 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal UNII lookup
95OOS7VE0YInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
53ab6046-058b-4cdf-8e4e-7ce6f5288701Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-003-01La Roche Posay Laboratoire Dermatologique Anthelios 60 Melt In Sunscreen Milk Broad Spectrum SPF 60 Face and Body150 mL in 1 TUBELOTION1504
49967-003-01La Roche Posay Laboratoire Dermatologique Anthelios 60 Melt In Sunscreen Milk Broad Spectrum SPF 60 Face and Body1 in 1 CARTONLOTION14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXLA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 60 MELT IN SUNSCREEN MILK BROAD SPECTRUM SPF 60 FACE AND BODY (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [L'OREAL USA PRODUCTS INC]1
HOMOSALATEACTIVE INGREDIENTV06SV4M95SLA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 60 MELT IN SUNSCREEN MILK BROAD SPECTRUM SPF 60 FACE AND BODY (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [L'OREAL USA PRODUCTS INC]1
OCTISALATEACTIVE INGREDIENT4X49Y0596WLA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 60 MELT IN SUNSCREEN MILK BROAD SPECTRUM SPF 60 FACE AND BODY (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [L'OREAL USA PRODUCTS INC]1
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WMLA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 60 MELT IN SUNSCREEN MILK BROAD SPECTRUM SPF 60 FACE AND BODY (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [L'OREAL USA PRODUCTS INC]1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YLA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 60 MELT IN SUNSCREEN MILK BROAD SPECTRUM SPF 60 FACE AND BODY (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [L'OREAL USA PRODUCTS INC]1
AVOBENZONEACTIVE MOIETYG63QQF2NOXLA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 60 MELT IN SUNSCREEN MILK BROAD SPECTRUM SPF 60 FACE AND BODY (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [L'OREAL USA PRODUCTS INC]1
HOMOSALATEACTIVE MOIETYV06SV4M95SLA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 60 MELT IN SUNSCREEN MILK BROAD SPECTRUM SPF 60 FACE AND BODY (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [L'OREAL USA PRODUCTS INC]1
OCTISALATEACTIVE MOIETY4X49Y0596WLA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 60 MELT IN SUNSCREEN MILK BROAD SPECTRUM SPF 60 FACE AND BODY (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [L'OREAL USA PRODUCTS INC]1
OCTOCRYLENEACTIVE MOIETY5A68WGF6WMLA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 60 MELT IN SUNSCREEN MILK BROAD SPECTRUM SPF 60 FACE AND BODY (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [L'OREAL USA PRODUCTS INC]1
OXYBENZONEACTIVE MOIETY95OOS7VE0YLA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 60 MELT IN SUNSCREEN MILK BROAD SPECTRUM SPF 60 FACE AND BODY (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [L'OREAL USA PRODUCTS INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-003LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 60 MELT IN SUNSCREEN MILK BROAD SPECTRUM SPF 60 FACE AND BODY (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [L'OREAL USA PRODUCTS INC]4Current NDC, Legacy NDC, 2 package rows20240101_53ab6046-058b-4cdf-8e4e-7ce6f5288701.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 224 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COOLA Classic Liplux Lip Balm SPF 30 TintedAVOBENZONE, OCTISALATE, OCTOCRYLENECOOLA, LLCeec6e7c8-17fe-f34b-e053-2995a90a78a02025-02-20WarningsExact identifier
application number: M020
DropsAVOBENZONE OCTISALATE OCTOCRYLENEVacation Inc.1319d6ea-a580-79c5-e063-6394a90a4dca2025-02-20WarningsExact identifier
application number: M020
Vacation SPF 50 Super Spritz Face MistAVOBENZONE, OCTISALATE, OCTOCRYLENEVacation Inc.f67fbe98-93ce-2882-e053-2a95a90ab7132025-02-20WarningsExact identifier
application number: M020
REPAIRWEAR UPLIFTING FIRMING BROAD SPECTUM SPF 15 - NORMAL COMBO TO COMBINATION oilyOCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDECLINIQUE LABORATORIES LLC10edc0c1-9359-4c7a-a56e-bad06fea00562025-02-20WarningsExact identifier
application number: M020
Mineral SPF 30 Brush-On Sun DefenseZINC OXIDEMineral Fusion29733dba-8824-461e-be44-335d6fe50d602025-02-19WarningsExact identifier
application number: M020
Neutrogena Healthy Skin Invisibly Radiant UV Primer SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLC20cd4d96-2046-3a50-e063-6394a90a12192025-02-18WarningsExact identifier
application number: M020
COOLA Classic Body SPF 30 Pina ColadaAVOBENZONE, OCTISALATE, OCTOCRYLENECOOLA, LLCedc59de7-c817-1a59-e053-2995a90a34082025-02-17WarningsExact identifier
application number: M020
Liplux SPF 30 Lip BalmCLASSICCOOLA LLCb47b5f3a-43f3-ae7a-e053-2995a90ae16d2025-02-17WarningsExact identifier
application number: M020
COOLA Classic Body SPF 50 Fragrance FreeAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA, LLCed207afe-0b10-74c7-e053-2a95a90a9b872025-02-17WarningsExact identifier
application number: M020
Avon Skin-So-Soft Bug Guard plus SPF 30 Sunscreen Gentle Breeze Insect Repellent SunscreenOCTINOXATE, OXYBENZONE, OCTISALATEThe Avon Company2e5d6c93-f091-5388-e063-6394a90ad5602025-02-17WarningsExact identifier
application number: M020
KEYS SOULCARE DAILY MOISTURIZER BROAD SPECTRUM SPF30 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc31a98dc7-4b99-d845-e063-6394a90a26702025-02-17WarningsExact identifier
application number: M020
Ultra sheer mineral sunscreen PRO SPF30ZINC OXIDEEden Brands Inc.2ce06566-2eb0-9a00-e063-6394a90a9ba92025-02-14WarningsExact identifier
application number: M020
Cell Fusion C Laser UV Defense Sunscreen Broad Spectrum SPF 50HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDECMS LAB Inc.2dff0386-e151-089a-e063-6394a90a0f532025-02-14WarningsExact identifier
application number: M020
Cell Fusion C Airy Stick Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECMS LAB Inc.2dffc699-3b56-2c70-e063-6294a90ae2492025-02-14WarningsExact identifier
application number: M020
Sun Defense Minerals (Sheer)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e2082aa-5ae3-2c04-e063-6294a90a140b2025-02-14WarningsExact identifier
application number: M020
Coola SPF 30 Mineral Sunscreen Fragrance FreeZINC OXIDECOOLA, LLCedc6048e-0ea0-41c5-e053-2a95a90a96d92025-02-14WarningsExact identifier
application number: M020
COOLA Classic Body SPF 50 Guava MangoAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA, LLCed13afaa-35ec-8326-e053-2995a90adaf02025-02-14WarningsExact identifier
application number: M020
Sun Defense Minerals (Light)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e21f5bb-e7df-b43b-e063-6394a90a0f822025-02-14WarningsExact identifier
application number: M020
Sun Defense Minerals (Fair)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e2102c6-02ea-3a8f-e063-6394a90abf5e2025-02-14WarningsExact identifier
application number: M020
Sunscreen Broad Spectrum SPF 50 Vi AestheticsZINC OXIDE, OCTINOXATEVi Medical Products, INC73620765-c7c0-4bd7-82a9-00022773c9282025-02-14WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49967-003-01499670003011 TUBE in 1 CARTON (49967-003-01) / 150 mL in 1 TUBE1 tube2013-06-010000-00-00NoNoCurrent