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 firm2026-10-21

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 138 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SHADEDTITANIUM DIOXIDE, ZINC OXIDEPotency No. 710 LLC31177bbd-68b0-8b24-e063-6294a90aa8d82025-12-10WarningsExact identifier
application number: M020
SHADEDTITANIUM DIOXIDE, ZINC OXIDEPotency No. 710 LLC3117e138-83a1-0931-e063-6394a90abe432025-12-10WarningsExact identifier
application number: M020
SHADEDTITANIUM DIOXIDE, ZINC OXIDEPotency No. 710 LLC31188175-a4ca-449f-e063-6394a90a3c052025-12-10WarningsExact identifier
application number: M020
COVEREDZINC OXIDEPotency No. 710 LLC3118c3ed-f0f0-f997-e063-6294a90a53a92025-12-10WarningsExact identifier
application number: M020
COVEREDZINC OXIDEPotency No. 710 LLC3117faeb-1792-1b2e-e063-6294a90a92df2025-12-10WarningsExact identifier
application number: M020
Non-Tinted Mineral Foaming SunscreenTITANIUM DIOXIDE, ZINC OXIDERestore Skin Therapy, LLC364b6af2-a0ed-4a17-e063-6394a90a3a172025-12-10Exact identifier
application number: M020
Morning ReplenishZINC OXIDERestore Skin Therapy, LLC364b26c2-a1bb-9660-e063-6294a90a14d12025-12-10Exact identifier
application number: M020
Glass Skin Sunscreen TintedZINC OXIDEFleur de Lune, LLC34288989-35b8-3aa3-e063-6394a90ac2c42025-12-10Exact identifier
application number: M020
Glass Skin Sunscreen TintedZINC OXIDEFleur de Lune, LLC3418394b-fede-65ce-e063-6394a90ad5f92025-12-10Exact identifier
application number: M020
Glass Skin Sunscreen Non-TintedZINC OXIDEFleur de Lune, LLC341871e5-c170-7560-e063-6394a90a8eee2025-12-10Exact identifier
application number: M020
Glass Skin Sunscreen Non-TintedZINC OXIDEFleur de Lune, LLC3428bdbb-1f18-a29b-e063-6294a90addbc2025-12-10Exact identifier
application number: M020
Sheer Facial Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEBB MEDICAL & DERMATOLOGY INC342b2403-4f4a-3e77-e063-6294a90a4f0a2025-12-10Exact identifier
application number: M020
Sheer Mineral Sunscreen BarTITANIUM DIOXIDE, ZINC OXIDEBB MEDICAL & DERMATOLOGY INC342b69d5-f0e1-99cd-e063-6294a90abb6e2025-12-10Exact identifier
application number: M020
Sheer Facial Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEBB MEDICAL & DERMATOLOGY INC342c3f42-c17f-f777-e063-6394a90a80582025-12-10Exact identifier
application number: M020
Lip SPFTITANIUM DIOXIDE, ZINC OXIDEFRANCISCO FLORES, M.D., P.A.396d3fdd-99d8-77e8-e063-6294a90aec2f2025-12-10Exact identifier
application number: M020
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEFRANCISCO FLORES, M.D., P.A.396cae82-7641-e1b2-e063-6394a90a7c072025-12-10Exact identifier
application number: M020
Solar Knight SPF 40 Broad SpectrumTITANIUM DIOXIDE, ZINC OXIDEMASCARENAS ENTERPRISES, INC.36c27c91-22ac-205c-e063-6294a90ab3792025-12-10Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEFRANCISCO FLORES, M.D., P.A.396ce15a-06ad-4055-e063-6294a90a27fb2025-12-10Exact identifier
application number: M020
Dermablue Daily ReplenishingZINC OXIDEDermablue, P.C.308da9c9-544e-d5d1-e063-6294a90aa49b2025-12-10WarningsExact identifier
application number: M020
Recoverie Mineral MatteZINC OXIDEClear Day Acne Clinic308f41de-fb14-40f9-e063-6394a90a008f2025-12-10WarningsExact 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