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
Requested package NDC
49967-003-01
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 86 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ALOHA MINERAL BLOCK-BRUSH ON MINERALSUNSCREEN SPF50Aopline Biotechnology (Guangzhou) Co., Ltd.47dd07aa-71b4-5d54-e063-6394a90a41272026-01-08WarningsExact identifier
application number: M020
SUNSCREEN SETTING SPRITZ, SPF 45SUNSCREEN SETTING SPRAYAopline Biotechnology (Guangzhou) Co., Ltd.47ddf752-cae2-313f-e063-6294a90a7e3a2026-01-08WarningsExact identifier
application number: M020
St Moriz suncare face sunscreen spf50OCTOCRYLENE, OCTISALATE , AVOBENZONE , HOMOSALATEAopline Biotechnology (Guangzhou) Co., Ltd.47df072e-151f-eb30-e063-6294a90a4eeb2026-01-08WarningsExact identifier
application number: M020
SUNSCREEN GLOWINGAVOBENZONE ,OCTISALATE ,OCTOCRYLENE , HOMOSALATEAopline Biotechnology (Guangzhou) Co., Ltd.47df0de5-012a-c896-e063-6394a90a9cef2026-01-08WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEEdgewell Personal Care Brands LLC616d35f6-63d2-3d26-e053-2991aa0a5b442026-01-08WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEEdgewell Personal Care Brands LLC616d35a1-a139-1974-e053-2a91aa0a20b62026-01-08WarningsExact identifier
application number: M020
PIPA SKIN CARE SUN-SATIONAL Mineral SunscreenSPF 30EVI LABS258b7b7c-a3f2-172c-e063-6394a90aec6a2026-01-08WarningsExact identifier
application number: M020
DMK Ultrascreen Mineral SunscreenZINC OXIDEDanne Montague King3f022275-c1e5-2704-e063-6294a90a4a812026-01-08WarningsExact identifier
application number: M020
Anhydrous SPF 30TITANIUM DIOXIDE, ZINC OXIDEOwen Biosciences, Inc.0cc8221d-5ec5-4abf-a4f5-ab06e8dcea682026-01-08WarningsExact identifier
application number: M020
Rejuvaskin Mineral Facial Sunscreen SPF 32 SheerREJUVASKIN MINERAL FACIAL SUNSCREEN SPF 32 SHEERAtlantic Medical Products, LLC47e5198e-7bf6-72a8-e063-6294a90a7ec52026-01-08WarningsExact identifier
application number: M020
inde wild SUN DEFENSE SPF 50 SUNSCREEN GLOW DROPS BROAD SPECTRUMINDE WILD SUN DEFENSE GLOW DROPSINDE WILD PRIVATE LIMITED47e57407-2925-09ca-e063-6294a90a49ec2026-01-08WarningsExact identifier
application number: M020
NIDA Invisible Fit SunscreenSUNSCREENProso Corp47ed3b62-45ef-b67a-e063-6294a90a317b2026-01-08WarningsExact identifier
application number: M020
Organic Matters SPF 50 SunscreenZINC OXIDEVeganic SKN Limited12f37c8d-07f0-3e75-e063-6294a90a2cdf2026-01-08WarningsExact identifier
application number: M020
Ellegreen Sunscreen Broad Spectrum SPF50ZINC OXIDEVeganic SKN Limited161a7209-10d8-928c-e063-6394a90a41392026-01-08WarningsExact identifier
application number: M020
Live Sunny Eco-zinc hydrating mineral sunscreen for body and faceZINC OXIDEVeganic SKN Limited1a97169e-67be-3d25-e063-6294a90a3b882026-01-08WarningsExact identifier
application number: M020
Dr Loretta Universal Glow Daily Defense SPF 40ZINC OXIDEDr. Loretta, LLC1208d0f8-bb12-4574-b70e-3a76b11a64c72026-01-07WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Face Sunscreen SPF 60AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKDC/One Development Corporation, Inc.259f3fe3-2967-6c05-e063-6394a90a9e452026-01-07WarningsExact identifier
application number: M020
Hawaiian Blend Extreme Zinc SPF 30ZINC OXIDE, TITANIUM DIOXIDEThe Islander Group4084dd98-357f-4011-b0d4-db6536d2931f2026-01-07WarningsExact identifier
application number: M020
Hawaiian Blend Extreme Zinc SPF 50ZINC OXIDE, TITANIUM DIOXIDEThe Islander Group9b4acc5e-fdaf-4fcb-83a9-69e430dd43de2026-01-07WarningsExact identifier
application number: M020
Hawaiian Blend Sensitive Zinc SPF 50ZINC OXIDE, TITANIUM DIOXIDEThe Islander Groupb42261c5-fa6e-4bb3-93c0-97032ab9f7162026-01-07WarningsExact 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