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 73 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade SevenZINC OXIDEClean Beauty For All, Inc (dba Saie)310a07bb-d32a-401f-955e-4c2860148a302026-01-20WarningsExact identifier
application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade FiveZINC OXIDEClean Beauty For All, Inc (dba Saie)39ae4a97-7f96-4c95-a6de-0c779764fb022026-01-20WarningsExact identifier
application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Four and HalfZINC OXIDEClean Beauty For All, Inc (dba Saie)1922fc3e-055c-e51d-e063-6294a90a00f52026-01-20WarningsExact identifier
application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade NineZINC OXIDEClean Beauty For All, Inc (dba Saie)9c7a31df-5bdd-403b-b807-1d1a801e1bb62026-01-20WarningsExact identifier
application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade OneZINC OXIDEClean Beauty For All, Inc (dba Saie)1922fc51-ae53-acb8-e063-6394a90a14eb2026-01-20WarningsExact identifier
application number: M020
Wrinkle Repair Moisturizer SPF 30 EQBAVOBENZONE 2% HOMOSALATE 4% OCTISALATE 4% OCTOCRYLENE 2%Walmarta067e968-e598-40ef-95f2-c338b5e413dd2026-01-20WarningsExact identifier
application number: M020
Welmedix HomeCare PRO Fragile Skin Dual Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEWelmedix LLC48da4589-0f5a-c25b-e063-6394a90ac18b2026-01-20WarningsExact identifier
application number: M020
SPF 50 Mineral Sunscreen KidsZINC OXIDE 14.69%S&C Hampton Sun LLC0bdb7d15-dc52-4e23-9417-fe73f17f61102026-01-20WarningsExact identifier
application number: M020
DEWYTREE URBAN SHADE INVISIBLE SMOOTHING PORE SUNSTIC SUNSTICKOCTOCRYLENE, HOMOSALATE, ZINC OXIDE, OCTISALATEDEWYTREE CO. ,LTD48406e68-eefd-d2c2-e063-6394a90a4ad92026-01-20WarningsExact identifier
application number: M020
KONEUK SUNSCREEN SPF50KONEUK SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.48dd7f6e-2a4d-2c92-e063-6294a90a42552026-01-20WarningsExact identifier
application number: M020
CHUDAAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATEPremier Ocher LLC1bc2a2df-a4cd-45e7-93c6-b35dbd8b280f2026-01-20WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2CR Cool FosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior12edec55-2414-4bbd-bc96-4599a96b96ac2026-01-19WarningsExact identifier
application number: M020
PROJECT REEF SPF-30 Mineral SunscreenZINC OXIDEProject Reef LLCa6077e6f-d987-4159-946f-3e23972476592026-01-19WarningsExact identifier
application number: M020
OUTER REEF MINERAL SUNSCREEN SPF 30TITANIUM DIOXIDECoral Reef Park Co., Inc.86ee2fdf-8a88-44e6-b12a-36a92360477a2026-01-19WarningsExact identifier
application number: M020
SABAL Mineral Sunscreen Broad Sprectrum SPF 30ZINC OXIDESABAL SUN LLCf917b446-4e10-4231-826e-fdac32e111862026-01-19WarningsExact identifier
application number: M020
Plius Daily SPF Moisturizer SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEPLIUS, Inc31866de9-afa0-4c11-be65-b613735514932026-01-19WarningsExact identifier
application number: M020
PROTEKT SPF-50 Sheer Mineral SunscreenZINC OXIDEProtekt Products, Inc.6edc0941-bb21-4797-a875-81f7276947742026-01-19WarningsExact identifier
application number: M020
Ultra Violette SPF Mini Mates Duo Pocket Pals Ultra Violette SPF Mini Mates Duo Pocket Pals Contains 1 X Supreme Screen SPF50 20mL (84803-100-21) 1 X Future Screen SPF50 20mL (84803-103-21)ACTIVE INGREDIENTS SUPREME SCREEN SPF 50 AVOBENZONE 3% HOMOSALATE 7% OCTISALATE 5% OCTOCRYLENE 8% ACTIVE INGREDIENTS FUTURE SCREEN SPF 50 ZINC OXIDE 20%Grace and Fire USA Inc.48c1b93c-9c6f-95aa-e063-6294a90a0cfa2026-01-19WarningsExact identifier
application number: M020
ANUA INVISIBLE GLOW FINISH SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEThe Founders Inc.446ac344-1078-4cd1-e063-6294a90a4bd42026-01-19WarningsExact identifier
application number: M020
ANUA ZERO-CAST MOISTURIZING FINISH SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEThe Founders Inc.31af7b5e-2bd6-63ee-e063-6294a90a08062026-01-19WarningsExact 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