FDA.reportPublic FDA data

La Roche Posay Laboratoire Dermatologique

Product NDC
49967-907
11-digit product format
499670907
Labeler code
49967
Product ID
49967-907_93f2cacd-67af-4ad8-9e0a-4de8330f808f
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium dioxide and Zinc oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
L'Oreal USA Products Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-07-01
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
60; 50 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage49967-90749967-907-02DDiscontinued by firm2026-10-23

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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 Mineral Ultra Light Sunscreen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE60 mg/mL
ZINC OXIDE50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2ce83dc2-84b6-43fd-8b11-495d41cebc22Available 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
49967-907-01La Roche Posay Laboratoire DermatologiqueAnthelios 50 Mineral Ultra Light Sunscreen50 mL in 1 BOTTLE, PLASTICLOTION5017
49967-907-01La Roche Posay Laboratoire DermatologiqueAnthelios 50 Mineral Ultra Light Sunscreen1 in 1 CARTONLOTION117
49967-907-02La Roche Posay Laboratoire DermatologiqueAnthelios 50 Mineral Ultra Light Sunscreen3 mL in 1 TUBELOTION317
49967-907-02La Roche Posay Laboratoire DermatologiqueAnthelios 50 Mineral Ultra Light Sunscreen1 in 1 CARTONLOTION117
49967-907-03La Roche Posay Laboratoire DermatologiqueAnthelios 50 Mineral Ultra Light Sunscreen5 mL in 1 TUBELOTION517
49967-907-03La Roche Posay Laboratoire DermatologiqueAnthelios 50 Mineral Ultra Light Sunscreen1 in 1 CARTONLOTION117

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Titanium dioxideACTIVE INGREDIENT15FIX9V2JPLA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 50 MINERAL ULTRA LIGHT SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [L'OREAL USA PRODUCTS INC]7
Zinc oxideACTIVE INGREDIENTSOI2LOH54ZLA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 50 MINERAL ULTRA LIGHT SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [L'OREAL USA PRODUCTS INC]7
Titanium dioxideACTIVE MOIETY15FIX9V2JPLA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 50 MINERAL ULTRA LIGHT SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [L'OREAL USA PRODUCTS INC]7
Zinc oxideACTIVE MOIETYSOI2LOH54ZLA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 50 MINERAL ULTRA LIGHT SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [L'OREAL USA PRODUCTS INC]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-907LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 50 MINERAL ULTRA LIGHT SUNSCREEN (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [L'OREAL USA PRODUCTS INC]17Current NDC, Legacy NDC, 6 package rows20231214_2ce83dc2-84b6-43fd-8b11-495d41cebc22.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 164 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SOME BY MI V10 HYAL AIR FIT SUNSCREENSUNSCREENTPERENNEBELLfe2148db-9020-9343-e053-6294a90adf702025-11-13WarningsExact identifier
application number: M020
skin MDOCTINOXATE, OCTISALATE, HOMOSALATE21st Century Formulationse809e1d3-0a6d-730d-e053-2a95a90aedb92025-11-13WarningsExact identifier
application number: M020
Obagi Nu-Derm Fx System Normal-Oily Skin Transformation Complexion Brightening SystemTITANIUM DIOXIDE, ZINC OXIDEObagi Cosmeceuticals LLCa64045dd-8f70-43f1-be6f-ad1556c0e2102025-11-13WarningsExact identifier
application number: M020
Florida Glow SPF 50AVOBENZONE,OCTOCRYLENE,OCTISALATE,HOMOSALATESoutheast Holdings Corp.dcb43ee0-5ab0-495a-8e68-90cab881337d2025-11-12WarningsExact identifier
application number: M020
Florida Glow SPF 30AVOBENZONE,OCTOCRYLENE,OCTISALATE,HOMOSALATESoutheast Holdings Corp.20538bc0-10c3-492c-952a-6797e46003f22025-11-12WarningsExact identifier
application number: M020
Florida Glow SPF 15AVOBENZONE,OCTOCRYLENE,OCTISALATESoutheast Holdings Corp.56af704a-bda9-49ed-a177-a8480d90458b2025-11-12WarningsExact identifier
application number: M020
Florida Glow face shield SPF 55HOMOSALATE, OCTOCRYLENE, ZINC OXIDESoutheast Holdings Corp.cea54600-5308-4b9f-98ca-fef0b26d79c12025-11-12WarningsExact identifier
application number: M020
Florida Glow SPF 30ZINC OXIDESoutheast Holdings Corp.4bf1ca6b-5d87-40ee-97f4-89f1bfadcecb2025-11-12WarningsExact identifier
application number: M020
TuroSkin Daily Moisturizing Sunscreen broadspectrum spf15AVOBENZONE,HOMOSALATE,OCTISALATERenuskin LLCe36efd74-11c2-4850-9529-1c88b7364a332025-11-12WarningsExact identifier
application number: M020
TuroSkin Sport Sunscreen Broad Spectrum SPF 30 WR SR 80minAVOBENZONE,HOMOSALATE,OCTISALATERenuskin LLC22a40d93-ca67-4b7d-a95c-22f52cd6d2972025-11-12WarningsExact identifier
application number: M020
ZEUSZINC OXIDENEWPORT APOTHECARY, INC5354c383-08f0-4b89-b36a-96a35f47be3c2025-11-12WarningsExact identifier
application number: M020
Practical Alchemy Hydrating SPF 30ZINC OXIDEOver Here, LLC2f07df5b-dbd4-494c-a7cf-55843fb4d7c22025-11-12WarningsExact identifier
application number: M020
Dr Lift SPF 50 Mineral Sunscreen StickZINC OXIDESpa de Soleil436fdf4f-11db-7c5b-e063-6294a90a87312025-11-12WarningsExact identifier
application number: M020
CeraVe Developed with Dermatologists Skin Renewing Brightening with Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEL'Oreal USA Products Inc3676aa91-c90d-4a7a-b02e-d5b35304a04d2025-11-12WarningsExact identifier
application number: M020
HYDRATING GLOW MIST SPF 50AVOBENZONE, OCTISALATE, OCTOCRYLENENAKED SUNDAYS PTY LTDdf3bd18d-63b4-460f-bf1c-115ad35edd962025-11-11WarningsExact identifier
application number: M020
Zinka Clear Zinc Oxide SunscreenOCTINOXATE, ZINC OXIDE, OCTISALATE, OXYBENZONEZinka, Inc.7b097f5e-8127-49e6-8a77-4ee1fded5ff12025-11-11WarningsExact identifier
application number: M020
Total Sun ProtectionOCTINOXATE, OCTISALATE, OXYBENZONE, ZINC OXIDECosmed Dermaceuticals, Inc.dbb16ef1-ab8c-4e71-a2a2-a507d104ff0f2025-11-11WarningsExact identifier
application number: M020
Sunsorb Reef Safe SPF15HOMOSALATE, OCTOCRYLENE, AVOBENZONEQS Key West Aloe, LLC1a1c17c4-4912-4573-9f59-cbd14a014cb42025-11-11WarningsExact identifier
application number: M020
Sunsorb Reef Safe SPF30HOMOSALATE, OCTOCRYLENE, AVOBENZONEQS Key West Aloe, LLC14f65b3d-90bf-4689-aa6e-879e06153db92025-11-11WarningsExact identifier
application number: M020
Sunsorb Reef Safe SPF50HOMOSALATE, ZINC OXIDE, OCTOCRYLENEQS Key West Aloe, LLCb4fc7a51-a163-4057-8790-f2111668ec672025-11-11WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49967-907-01499670907011 BOTTLE, PLASTIC in 1 CARTON (49967-907-01) / 50 mL in 1 BOTTLE, PLASTIC2011-07-010000-00-00NoNoCurrent
49967-907-02499670907021 TUBE in 1 CARTON (49967-907-02) > 3 mL in 1 TUBE1 tube2011-07-010000-00-00NoNoCurrent
49967-907-03499670907031 TUBE in 1 CARTON (49967-907-03) / 5 mL in 1 TUBE1 tube2019-12-020000-00-00NoNoCurrent