FDA.reportPublic FDA data

La Roche Posay Laboratoire Dermatologique Anthelios Kids Gentle Broad Spectrum SPF 50 Sunscreen for Face and Body Water Resistant 80 Minutes

Product NDC
49967-603
11-digit product format
499670603
Labeler code
49967
Product ID
49967-603_d878b502-3836-4ab9-a216-3c0759b7ab11
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
2022-10-01
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
30; 130; 50; 100 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 Kids Gentle Broad Spectrum SPF 50 Sunscreen for Face and Body Water Resistant 80 Minutes
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/mL
HOMOSALATE130 mg/mL
OCTISALATE50 mg/mL
OCTOCRYLENE100 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
8a2fd46c-5767-4621-8e69-dd291f9fe5b1Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-603-01La Roche Posay Laboratoire Dermatologique Anthelios Kids Gentle Broad Spectrum SPF 50 Sunscreen for Face and Body Water Resistant 80 Minutes200 mL in 1 TUBELOTION2007
49967-603-02La Roche Posay Laboratoire Dermatologique Anthelios Kids Gentle Broad Spectrum SPF 50 Sunscreen for Face and Body Water Resistant 80 Minutes5 mL in 1 TUBELOTION57
49967-603-03La Roche Posay Laboratoire Dermatologique Anthelios Kids Gentle Broad Spectrum SPF 50 Sunscreen for Face and Body Water Resistant 80 Minutes2 mL in 1 PACKETLOTION27
49967-603-04La Roche Posay Laboratoire Dermatologique Anthelios Kids Gentle Broad Spectrum SPF 50 Sunscreen for Face and Body Water Resistant 80 Minutes1 in 1 CARTONLOTION17
49967-603-04La Roche Posay Laboratoire Dermatologique Anthelios Kids Gentle Broad Spectrum SPF 50 Sunscreen for Face and Body Water Resistant 80 Minutes15 mL in 1 TUBELOTION157
49967-603-05La Roche Posay Laboratoire Dermatologique Anthelios Kids Gentle Broad Spectrum SPF 50 Sunscreen for Face and Body Water Resistant 80 Minutes90 mL in 1 TUBELOTION907
49967-603-05La Roche Posay Laboratoire Dermatologique Anthelios Kids Gentle Broad Spectrum SPF 50 Sunscreen for Face and Body Water Resistant 80 Minutes1 in 1 CARTONLOTION17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-603LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS KIDS GENTLE BROAD SPECTRUM SPF 50 SUNSCREEN FOR FACE AND BODY WATER RESISTANT 80 MINUTES (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) LOTION [L'OREAL USA PRODUCTS INC]7Current NDC, Legacy NDC, 7 package rows20240102_8a2fd46c-5767-4621-8e69-dd291f9fe5b1.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 67 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SHISEIDO SPORTS BB DARKOCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONf4fc4b6a-9507-496e-9ecb-8400055ecf2d2026-01-28WarningsExact identifier
application number: M020
Hampton Sun SPF 30 MineralZINC OXIDE 7.20% TITANIUM DIOXIDE 4.00%S&C Hampton Sun LLCb8ee428e-07d3-4c6c-853c-cfbe3e4002d92026-01-28WarningsExact identifier
application number: M020
SHISEIDO FUTURE LX UNIVERSAL DEFENSE SOCTISALATE, OCTOCRYLENE, AND ZINC OXIDESHISEIDO AMERICAS CORPORATION0a6f8eef-48e9-44f5-9811-629bc0dc07d02026-01-28WarningsExact identifier
application number: M020
Hampton Sun SPF 45 Tinted FaceHOMOSALATE 10% OCTOCRYLENE 6% AVOBENZONE 3%S&C Hampton Sun LLC0fc0f2c7-ec0f-4976-9872-82a6bfe8b46b2026-01-28WarningsExact identifier
application number: M020
Walgreens 70 Sport SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY49775d1a-e573-a596-e063-6294a90a7cf62026-01-28WarningsExact identifier
application number: M020
AVON ANEW ULTIMATE MULTI-PERFORMANCE DAY BROAD SPECTRUM SPF 25 SUNSCREENAVOBENZONE, HOMOSALATE, OCTINOXATE, OXYBENZONEThe Avon Company49784430-2ffe-0cbb-e063-6394a90adb232026-01-28WarningsExact identifier
application number: M020
ALOE UP SPORT SPF-50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAloe Care International, LLC3f2f90f1-28dd-48e8-9083-ea04815acc6b2026-01-28WarningsExact identifier
application number: M020
ALOE UP PRO 30 CONTINUOUS SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEAloe Care International, LLCbaf32d84-4db5-4ed0-9814-5470b7d1f4a42026-01-28WarningsExact identifier
application number: M020
ALOE UP PRO 15AVOBENZONE, OCTISALATE, OCTOCRYLENEAloe Care International, LLC5b0f43fc-f4a6-4403-a40e-e0198a6f2ebd2026-01-28WarningsExact identifier
application number: M020
ALOE UP PRO 50 CONTINUOUS SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEAloe Care International, LLCdc33d9e8-3463-485d-a1ee-6319ed91454c2026-01-28WarningsExact identifier
application number: M020
ALOE ICE SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEAloe Care International, LLCe4b861d2-3680-4ed7-8650-d1d839da5ab22026-01-28WarningsExact identifier
application number: M020
ALOE UP SPORT SPF-15AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAloe Care International, LLC1bf1635a-825e-417f-97b4-4bce6d251d192026-01-28WarningsExact identifier
application number: M020
Mineral SunscreenZINC OXIDE 20%The Daily Suncare LLC, DBA Daily Shade1a392f6b-1bb1-c49d-e063-6294a90a791d2026-01-28WarningsExact identifier
application number: M020
KIZO LAB UV DEFENSE CLEAR SUNSCREN SPF50AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEYB CHEMIA LLC0053ae49-b9a1-c3f4-e063-6394a90abcb82026-01-28WarningsExact identifier
application number: M020
Orange GelAVOBENZONE OCTISALATE OCTOCRYLENE HOMOSALATEVacation Inc.132896ef-d6c6-4ec7-e063-6294a90a103b2026-01-28WarningsExact identifier
application number: M020
REDEFINE Triple DefenseAVOBENZONE, OCTISALATE, OCTOCRYLENERodan & Fieldsd1dd62c6-33ac-4941-ab99-9eb8cc3c208a2026-01-27WarningsExact identifier
application number: M020
Centellian24 Madeca Derma Shield Vital Airy Sun StickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE7054144e11009-ffcb-dd59-e063-6294a90add222026-01-27WarningsExact identifier
application number: M020
Sunscreen SPF50NON NANO ZINC OXIDESBS BILIMSEL BIO COZUMLER SANAYI VE TICARET ANONIM SIRKETI PINAR SUBESIc5d52f13-a649-9579-e053-2a95a90a062c2026-01-27WarningsExact identifier
application number: M020
ONSART Mineral Sunscreen SPF 50ZINC OXIDE 24%Guangzhou Huixue Biotechnology Co., Ltd.495e3266-a59f-42f7-e063-6394a90adfa32026-01-27WarningsExact identifier
application number: M020
Poolside Sun Daze Body Illuminator SPF 30 Shimmer SunscreenHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLC54868d6f-ae4c-476d-8c77-c4a72b13d2ea2026-01-27WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49967-603-0149967060301200 mL in 1 TUBE (49967-603-01) 200 ml2022-10-010000-00-00NoNoCurrent
49967-603-02499670603025 mL in 1 TUBE (49967-603-02) 5 ml2022-10-010000-00-00NoNoCurrent
49967-603-03499670603032 mL in 1 PACKET (49967-603-03) 2 ml2022-10-010000-00-00NoNoCurrent
49967-603-04499670603041 TUBE in 1 CARTON (49967-603-04) / 15 mL in 1 TUBE1 tube2022-10-01NoNoCurrent
49967-603-05499670603051 TUBE in 1 CARTON (49967-603-05) / 90 mL in 1 TUBE1 tube2022-10-01NoNoCurrent