FDA.reportPublic FDA data

La Roche Posay Laboratoire Dermatologique

Product NDC
49967-899
11-digit product format
499670899
Labeler code
49967
Product ID
49967-899_2af1e670-d87a-423c-a0dc-9aac07b4166a
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide
Dosage form
LOTION
Route
TOPICAL
Labeler
L'Oreal USA Products Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-06-01
Substance
TITANIUM DIOXIDE
Active strength
110 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
Brand name suffix
Anthelios 50 Tinted Mineral Sunscreen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE110 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6d3c5fc5-c818-46c4-8db3-cffcdcd56e06Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-899-01La Roche Posay Laboratoire DermatologiqueAnthelios 50 Tinted Mineral Sunscreen50 mL in 1 BOTTLE, PLASTICLOTION5021
49967-899-01La Roche Posay Laboratoire DermatologiqueAnthelios 50 Tinted Mineral Sunscreen1 in 1 CARTONLOTION121
49967-899-02La Roche Posay Laboratoire DermatologiqueAnthelios 50 Tinted Mineral Sunscreen3 mL in 1 TUBELOTION321
49967-899-02La Roche Posay Laboratoire DermatologiqueAnthelios 50 Tinted Mineral Sunscreen1 in 1 CARTONLOTION121
49967-899-03La Roche Posay Laboratoire DermatologiqueAnthelios 50 Tinted Mineral Sunscreen1 in 1 CARTONLOTION121
49967-899-03La Roche Posay Laboratoire DermatologiqueAnthelios 50 Tinted Mineral Sunscreen125 mL in 1 BOTTLELOTION12521

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Titanium DioxideACTIVE INGREDIENT15FIX9V2JPLA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 50 TINTED MINERAL SUNSCREEN (TITANIUM DIOXIDE) LOTION [L'OREAL USA PRODUCTS INC]13
Titanium DioxideACTIVE MOIETY15FIX9V2JPLA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 50 TINTED MINERAL SUNSCREEN (TITANIUM DIOXIDE) LOTION [L'OREAL USA PRODUCTS INC]13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-899LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 50 TINTED MINERAL SUNSCREEN (TITANIUM DIOXIDE) LOTION [L'OREAL USA PRODUCTS INC]21Current NDC, Legacy NDC, 6 package rows20240101_6d3c5fc5-c818-46c4-8db3-cffcdcd56e06.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 226 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sum 37 Micro Active Daily Moisture SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG HOUSEHOLD & HEALTH CARE LTD.2eea94e1-2409-8ad6-e063-6294a90a5df82025-03-03WarningsExact identifier
application number: M020
Sun Defense Minerals (Fair)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e21c9f9-acf8-997b-e063-6394a90ada3f2025-03-01WarningsExact identifier
application number: M020
Sun Defense Minerals (Medium)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e232e8d-4274-68bc-e063-6394a90a942b2025-03-01WarningsExact identifier
application number: M020
Sun Defense Minerals (Deep)ZINC OXIDEEminence Organic Skin Care2e23d463-fbc1-5718-e063-6294a90a72722025-03-01WarningsExact identifier
application number: M020
Sun Defense Minerals (Deep)ZINC OXIDEEminence Organic Skin Care2e24391f-4982-efae-e063-6394a90accaa2025-03-01WarningsExact identifier
application number: M020
FRUDIA Blueberry Hydrating Air Fit SunscreenOCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEWELCOS CO.,LTD.8b2a1baa-e528-48d6-9cd8-c3cb55e0641b2025-02-28WarningsExact identifier
application number: M020
BRUSH ON BLOCK SPF 50 MINERALZINC OXIDESPF Ventures, LLC2f1b5454-8bf5-b447-e063-6394a90a743a2025-02-27WarningsExact identifier
application number: M020
Clear Defense SPF 45ZINC OXIDE, OCTINOXATEPrivate Label Skin Cared681d92f-3501-4fca-b629-096341f20ab12025-02-27WarningsExact identifier
application number: M020
HA Physical Tint SPF 44ZINC OXIDE, TITANIUM DIOXIDEPrivate Label Skin Carea5e19d77-703e-41e0-9a02-19227dc6c8192025-02-27WarningsExact identifier
application number: M020
Physical Daily Defense Broad Spectrum Sunscreen SPF 40ZINC OXIDEPrivate Label Skin Care18444581-66a4-4eda-a8df-627fa3b4b98a2025-02-26WarningsExact identifier
application number: M020
BRUSH ON BLOCK SPF 50 MINERAL TRANSLUCENT ZINC ONLY REFILLZINC OXIDE/TITANIUM DIOXIDESPF Ventures, LLC2f069114-9ca8-aed4-e063-6394a90a46d82025-02-26WarningsExact identifier
application number: M020
Sei Bella Tinted BB Moisturizing Cream230 NMelaleuca Inc.2f133abb-cad2-2ac8-e063-6294a90aa4802025-02-26WarningsExact identifier
application number: M020
BRUSH ON BLOCK SPF 50 KIDS MINERALZINC OXIDESPF Ventures, LLC2f17b5fe-44da-964b-e063-6394a90ae6992025-02-26WarningsExact identifier
application number: M020
Sun Defense Minerals (Tan)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2efb73a6-601d-61a4-e063-6294a90af8252025-02-25WarningsExact identifier
application number: M020
Rida Hair Research InstituteAVOBENZONE,OCTISALATE,OCTOCRYLENERida LLCece9dfd8-5f40-49b4-a97e-d4e6ffdb1dca2025-02-25WarningsExact identifier
application number: M020
COOLA Classic Body SPF 70 Peach BlossomAVOBENZONE, OCTISALATE, OCTOCRYLENECOOLA, LLCed217698-f552-677e-e053-2995a90acb0a2025-02-25WarningsExact identifier
application number: M020
COOLA Classic Body SPF 30 Tropical CoconutAVOBENZONE, OCTISALATE, OCTOCRYLENECOOLA, LLCed0f8249-aba8-b67c-e053-2a95a90af7eb2025-02-25WarningsExact identifier
application number: M020
Hydro Essence Broad Spectrum Sunscreen SPF 40ZINC OXIDE, OCTINOXATEPrivate Label Skin Caref176c1b1-f539-417f-98b5-69d99365f2f22025-02-25WarningsExact identifier
application number: M020
Sun Defense Minerals (Tan)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2ee82379-6609-fd8e-e063-6294a90acf6c2025-02-24WarningsExact identifier
application number: M020
Vacation SPF 50 ClassicAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEVacation Inc.f2780cb5-063c-10d3-e053-2995a90a85762025-02-24WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49967-899-01499670899011 BOTTLE, PLASTIC in 1 CARTON (49967-899-01) / 50 mL in 1 BOTTLE, PLASTIC2012-06-010000-00-00NoNoCurrent
49967-899-02499670899021 TUBE in 1 CARTON (49967-899-02) / 3 mL in 1 TUBE1 tube2012-06-010000-00-00NoNoCurrent
49967-899-03499670899031 BOTTLE in 1 CARTON (49967-899-03) / 125 mL in 1 BOTTLE1 bottle2012-06-010000-00-00NoNoCurrent