FDA.reportPublic FDA data

La Roche Posay Laboratoire Dermatologique Anthelios Dermo Kids Gentle Face and Body Broad Spectrum SPF 60 Sunscreen Water Resistant 80 Minutes

Product NDC
49967-374
11-digit product format
499670374
Labeler code
49967
Product ID
49967-374_489ddddd-5b3e-47af-ad63-224c94a23fc4
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate and Octocrylene
Dosage form
LOTION
Route
TOPICAL
Labeler
L'Oreal USA Products Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-11-01
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
30; 100; 50; 70 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 Dermo Kids Gentle Face and Body Broad Spectrum SPF 60 Sunscreen Water Resistant 80 Minutes
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/mL
HOMOSALATE100 mg/mL
OCTISALATE50 mg/mL
OCTOCRYLENE70 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f296e5ef-728a-4d57-8d65-7d88b1f90f88Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-374-01La Roche Posay Laboratoire Dermatologique Anthelios Dermo Kids Gentle Face and Body Broad Spectrum SPF 60 Sunscreen Water Resistant 80 Minutes200 mL in 1 TUBELOTION2009
49967-374-02La Roche Posay Laboratoire Dermatologique Anthelios Dermo Kids Gentle Face and Body Broad Spectrum SPF 60 Sunscreen Water Resistant 80 Minutes300 mL in 1 TUBELOTION3009
49967-374-03La Roche Posay Laboratoire Dermatologique Anthelios Dermo Kids Gentle Face and Body Broad Spectrum SPF 60 Sunscreen Water Resistant 80 Minutes3 mL in 1 PACKETLOTION39

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-374LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS DERMO KIDS GENTLE FACE AND BODY BROAD SPECTRUM SPF 60 SUNSCREEN WATER RESISTANT 80 MINUTES (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) LOTION [L'OREAL USA PRODUCTS INC]9Current NDC, Legacy NDC, 3 package rows20240101_f296e5ef-728a-4d57-8d65-7d88b1f90f88.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 102 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sugargirl Glowy SPF 30 Face Screen Solar Shimmer Sunscreen for the faceHOMOSALATE, OCTOCRYLENE, OCTISALATE, OCTINOXATE, AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.451bcab9-9b75-a17c-e063-6294a90aafd92025-12-23WarningsExact identifier
application number: M020
DECORTE AQ ABSOLUTE TREATMENT AWAKENING PROTECTIVE DAYAVOBENZONE, OCTINOXATE, OCTISALATEKOS America, Inc.81352963-36ec-4099-af51-3498d89f30772025-12-23WarningsExact identifier
application number: M020
Poolside Soft Serve Mineral Milk SPF 30 face sunscreen dropsZINC OXIDE, OCTINOXATELongway Technology(Guangzhou)Co.,Ltd.451b4d37-99e2-8e4f-e063-6294a90a51bb2025-12-23WarningsExact identifier
application number: M020
Reclaim Revolutionary Anti-Aging Day SPF15OCTINOXATE, OCTISALATE, AND OXYBENZONEGuthy-Renker LLC4b735c91-f650-4531-8744-c211d57a3e282025-12-23WarningsExact identifier
application number: M020
SCINIC ENJOY SUPER MILD SUN ESSENCE EXAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEELEVEN STREET35272744-8253-046c-e063-6394a90aabc22025-12-22WarningsExact identifier
application number: M020
TINTED FACIAL SUNSCREENZINC OXIDE, TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.1259035e-9196-97de-e063-6394a90a9dec2025-12-22WarningsExact identifier
application number: M020
SUNSCREEN LIP BALMETHYLHEXYL METHOXYCINNAMATE, HOMOSALATE, POLYSILICONE-15, OCTOCRYLENE, BUTYL METHOXYDIBENZOYLMETHANEGuangzhou Tata Biotechnology Co., Ltd.0f8e08bf-4b14-bdad-e063-6394a90a34e12025-12-22WarningsExact identifier
application number: M020
SUNSCREEN LIP PROTECTIONBROAD SPECTRUM SPF 15ETHYLHEXYL METHOXYCINNAMATE, OCTOCRYLENEGuangzhou Tata Biotechnology Co., Ltd.1c32b019-a038-eb61-e063-6394a90a45f22025-12-22WarningsExact identifier
application number: M020
SPF 50 MINERAL SUNSCREEN LIPZINC OXIDE , TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.1c6f0964-9bee-1c06-e063-6294a90ac2a42025-12-22WarningsExact identifier
application number: M020
Absolut Skin SPF 50 Moisturizing SunscreenETHYLHEXYL METHOXYCINNAMATE,ETHYLHEXYL SALICYLATE,METHYLENE BIS-BENZOTRIAZOLYL TETRAMETHYLBUTYLPHENOL,OCTOCRYLENEGuangzhou Tata Biotechnology Co., Ltd.3264543c-e8f5-da9a-e063-6394a90ac8c62025-12-22WarningsExact identifier
application number: M020
Firmarine Moisturizer SPF 30AVOBENZONE, OCTINOXATE, AND OCTISALATEErno Laszlo, Inc.073f8b95-6f46-4341-817f-22f5b4f325422025-12-22WarningsExact identifier
application number: M020
G.M. Collin FPS-SPF 50 UVA-UVB TINTED SUNSCREENZINC OXIDE, TITANIUM DIOXIDELABORATOIRES DERMO-COSMETIK INC.468c90d7-3b9e-1641-e063-6394a90a928c2025-12-22WarningsExact identifier
application number: M020
TiZO3TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.468d6476-127a-e9f0-e063-6294a90a3df92025-12-22WarningsExact identifier
application number: M020
YOUR SKIN BUT BETTER FAIRTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLC3e65ec1a-0ed9-433d-8da9-a6cb618299112025-12-22WarningsExact identifier
application number: M020
Sun Shades Sunscreen Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMelaleuca Inc.1f982f03-9542-29f9-e063-6294a90a959c2025-12-22WarningsExact identifier
application number: M020
SOLARA SUNCARE - GLOW GETTER SPF-30 NATURALLY SCENTEDZINC OXIDESOLARA SUNCARE, INC.ca99b8c4-6778-43dc-bdd5-ca4a470860a02025-12-22WarningsExact identifier
application number: M020
SOLARA SUNCARE - GO MINERAL DEFENSE SPORT SUPERFRUIT VITAMIN C PLUS ALOE SHEER SUNSCREEN MIST SPF-30 UNSCENTEDZINC OXIDESOLARA SUNCARE, INC.f810843b-5a4d-6cbc-e053-6294a90ac9e32025-12-22WarningsExact identifier
application number: M020
SOLARA SUNCARE - CLEAN FREAK SPF-30 NATURALLY SCENTEDZINC OXIDESOLARA SUNCARE, INC.7a5644b9-4368-4e9a-aa22-b3307acf43cc2025-12-22WarningsExact identifier
application number: M020
MINERAL DEFENSE SPORT CERAMIDE SPF-30ZINC OXIDESOLARA SUNCARE, INC.cbf9c715-2d45-4c1b-b58f-42795722821c2025-12-22WarningsExact identifier
application number: M020
SPF 50 Baby Sunscreen EquateAVOBENZONE, HOMOSALATE, OCTOCRYLENEWalmart Inc4690d89b-ae61-2ed5-e063-6294a90a743f2025-12-22WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49967-374-0149967037401200 mL in 1 TUBE (49967-374-01) 200 ml2016-11-010000-00-00NoNoCurrent
49967-374-0249967037402300 mL in 1 TUBE (49967-374-02) 300 ml2016-11-010000-00-00NoNoCurrent
49967-374-03499670374033 mL in 1 PACKET (49967-374-03) 3 ml2016-11-010000-00-00NoNoCurrent