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 59 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Naturalessa SPF50 MoisturizerZINC OXIDEAudrey Morris Cosmetics International, LLC816ddfa1-cb55-4591-a90b-71631cb176262026-02-26WarningsExact identifier
application number: M020
UV DEFENSE FACE MINERAL SPF 50ZINC OXIDEBETTER INVENTION LTD4b9a9efe-9aba-0ed0-e063-6394a90a2c6b2026-02-26WarningsExact identifier
application number: M020
MISTINE UV DEFENSE FACE SUNSCREEN SPF50AVOBENZONE, HOMOSOLATE, OCTISALATE, OCTOCRYLENEBETTER INVENTION LTD4b9a8f28-9043-8fb7-e063-6294a90a34d32026-02-26WarningsExact identifier
application number: M020
MISTINE UV INVISIBLE FACE SHEER SUNSCREEN SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBETTER INVENTION LTD4b9a8f28-9041-8fb7-e063-6294a90a34d32026-02-26WarningsExact identifier
application number: M020
Rationale The Discovery Travel KitZINC OXIDERATIONALE GROUP PTY LTD0c919aea-4bd4-427e-97e7-9c153b42f4912026-02-25WarningsExact identifier
application number: M020
Kiss My Face Purely Mineral Daily 50 Sunscreen SPF 50ZINC OXIDEWindmill Health Products, LLCebfb149c-0371-4492-b03a-5fdcb78217532026-02-25WarningsExact identifier
application number: M020
SHISEIDO UV PROTECTIVE COMPACT (REFILL) FAIR IVORYOCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONc05cef12-a6a7-4682-9357-6d77f4ca32672026-02-25WarningsExact identifier
application number: M020
cle de peau BEAUTE Protective DayAVOBENZONE, OCTINOXATE, OCTOCRYLENEShiseido Americas Corporationdea8e4c1-6a9c-44c6-abc8-6cdd50f35f492026-02-25WarningsExact identifier
application number: M020
Aura DefenseZINC OXIDEGrace and Glow MD LLC4ba75eff-74ef-278b-e063-6394a90a8ef02026-02-25WarningsExact identifier
application number: M020
AM Shield plusZINC OXIDEGrace and Glow MD LLC4ba7c282-c68e-8719-e063-6394a90a38142026-02-25WarningsExact identifier
application number: M020
cle de peau BEAUTE RADIANT FOUNDATION N M I10OCTINOXATE AND TITANIUM DIOXIDEShiseido Americas Corporation3be1fe06-bd3b-4078-bee9-d3caf8d068ff2026-02-25WarningsExact identifier
application number: M020
Jack BlackAVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUMJack Black L.L.C.4babe2ab-c5da-9a83-e063-6294a90aee4c2026-02-25WarningsExact identifier
application number: M020
Daily Facial Moisturizer SPF 25SUNSCREENPerson and Covey6b9258e4-c7c6-765e-e053-2991aa0a9f4e2026-02-25WarningsExact identifier
application number: M020
Jack BlackAVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUMJack Black L.L.C.4bac1c33-36fe-8d29-e063-6394a90a32a52026-02-25WarningsExact identifier
application number: M020
Jack BlackAVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUMJack Black L.L.C.4bac5550-c45f-a738-e063-6394a90ae5c82026-02-25WarningsExact identifier
application number: M020
Jack BlackAVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUMJack Black L.L.C.4baca374-7aaa-8d1d-e063-6394a90a5a552026-02-25WarningsExact identifier
application number: M020
Jack BlackAVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUMJack Black L.L.C.4bad1502-bc44-54ec-e063-6294a90ace8b2026-02-25WarningsExact identifier
application number: M020
Truskin SPF 30 Mineral Sunscreen Facial SerumZINC OXIDEAllure Labs2e20c132-8a03-1d5d-e063-6394a90ad2c32026-02-25WarningsExact identifier
application number: M020
Rationale The Brilliance Tinted Serum SPF 50ZINC OXIDERATIONALE GROUP PTY LTD5c38506b-1533-435f-87a6-0452bae5b29f2026-02-24WarningsExact identifier
application number: M020
FULLY RICE CERAMIDE MOISTURE SUNSCREENZINC OXIDEAdapt Inc.d8bfe222-3184-4c98-9876-ef5ac81772b62026-02-24WarningsExact 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