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 152 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BINDA Face and Body Sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED386f5013-430c-e07f-e063-6394a90a32a82025-12-04WarningsExact identifier
application number: M020
Poolside Not Your Babys Oil. SPF 30 sunscreen body oil.HOMOSALATE,OCTOCRYLENE,OCTISALATE,AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.452bcb25-848c-e8a7-e063-6394a90ace0f2025-12-04WarningsExact identifier
application number: M020
Sugargirl Glowy face screen sunbeam shimmer sunscreen for the face SPF 30HOMOSALATE, OCTOCRYLENE, OCTINOXATE, OCTISALATE, AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.452bd1d2-6a9f-f5e8-e063-6394a90ac9e32025-12-04WarningsExact identifier
application number: M020
Poolside Butter SCREEN SPF 30 sunscreen ButterHOMOSALATE , OCTOCRYLENE , OCTISALATE , AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.452bd24d-8654-e6c0-e063-6394a90a0aea2025-12-04WarningsExact identifier
application number: M020
Poolside Glow Butter Screen SPF 30 Shimmer sunscreen ButterHOMOSALATE , OCTOCRYLENE, OCTISALATE , AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.452bd69e-02c7-fcbd-e063-6394a90ae59b2025-12-04WarningsExact identifier
application number: M020
Softlips CherryDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Companybececc42-1321-430a-80ef-438060fdcc862025-12-04WarningsExact identifier
application number: M020
ATTITUDE Sunly Lip Balm SPF 15 WatermelonZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE450d038b-3f99-add8-e063-6294a90aee9a2025-12-03WarningsExact identifier
application number: M020
Natrience Broad Spectrum SPF 30SKIN SHIELDSisel International, LLC1989370f-68a6-6f22-e063-6394a90aacaf2025-12-03Boxed warning, WarningsExact identifier
application number: M020
ATTITUDE Super leaves Lip Balm SPF 15 CoconutZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE450d8fd0-20ad-1920-e063-6394a90a72712025-12-03WarningsExact identifier
application number: M020
ATTITUDE Super leaves Lip Balm SPF 15 ExoticZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE450db2bb-1788-efc2-e063-6294a90a13c02025-12-03WarningsExact identifier
application number: M020
ATTITUDE Super leaves Lip Balm SPF 15 WatermelonZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE450dcc02-8bcb-6c07-e063-6394a90a5df42025-12-03WarningsExact identifier
application number: M020
ATTITUDE Sunly Mineral Sunscreen Face Stick SPF 50 UnscentedZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44acf513-ffe6-888c-e063-6394a90a9c5c2025-12-03WarningsExact identifier
application number: M020
ATTITUDE Sunly Baby Mineral Sunscreen Face Stick SPF 50 UnscentedZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE450e52a9-5a6b-112f-e063-6394a90af7ca2025-12-03WarningsExact identifier
application number: M020
ATTITUDE Sunly Kids Mineral Sunscreen Face Stick SPF 50 UnscentedZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE450e6eb7-f49e-296e-e063-6294a90a05a42025-12-03WarningsExact identifier
application number: M020
Attitude - Leaves Bar - Lip Balm - SPF 15 - MangoZINC OXIDE9055-7588 Qubec Inc. DBA Attitude359a7ebf-46a6-4e99-b43c-f585e9bc08d92025-12-03WarningsExact identifier
application number: M020
ATTITUDE Sunly Lip balm Unscented SPF 15ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0d95a2b7-288d-7b29-e063-6294a90ae46b2025-12-03WarningsExact identifier
application number: M020
Attitude - Lip Balm - SPF 15 - CoconutZINC OXIDEAttitude DBA 9055-7588 Qubec Inc.068af2ec-a666-45bf-b0e0-89d1b93dedf12025-12-03WarningsExact identifier
application number: M020
Cancer Council Invisible Fluid SPF50 PlusAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEVitality US Co.1629b02b-e9f3-0593-e063-6294a90a9aa52025-12-03WarningsExact identifier
application number: M020
PRO-TECT SPORTS SUNSCREENMERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONEBio-Medical & Pharmaceutical Manufacturing Corporation16994959-cade-06de-e054-00144ff88e882025-12-03WarningsExact identifier
application number: M020
PRO-TECT SPORTS SUNSCREENMERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONEBio-Medical & Pharmaceutical Manufacturing Corporation66bb06fb-33d2-4b57-a65f-66bcd187c6272025-12-03WarningsExact 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