FDA.reportPublic FDA data

La Roche Posay Laboratoire Dermatologique Anthelios UV Tone Broad Spectrum SPF 50 Sunscreen

Product NDC
49967-212
11-digit product format
499670212
Labeler code
49967
Product ID
49967-212_30e06498-a38a-439b-9aaa-d7a56cfd37d3
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
2024-01-11
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
30; 70; 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 UV Tone Broad Spectrum SPF 50 Sunscreen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/mL
HOMOSALATE70 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
46aa9917-52ac-4c57-afde-366d2d3ca200Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-212-01La Roche Posay Laboratoire Dermatologique Anthelios UV Tone Broad Spectrum SPF 50 Sunscreen50 mL in 1 TUBELOTION501
49967-212-01La Roche Posay Laboratoire Dermatologique Anthelios UV Tone Broad Spectrum SPF 50 Sunscreen1 in 1 CARTONLOTION11
49967-212-02La Roche Posay Laboratoire Dermatologique Anthelios UV Tone Broad Spectrum SPF 50 Sunscreen5 mL in 1 TUBELOTION51
49967-212-02La Roche Posay Laboratoire Dermatologique Anthelios UV Tone Broad Spectrum SPF 50 Sunscreen15 in 1 PACKAGELOTION151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-212LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS UV TONE BROAD SPECTRUM SPF 50 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) LOTION [L'OREAL USA PRODUCTS INC]1Current NDC, 4 package rows20241225_46aa9917-52ac-4c57-afde-366d2d3ca200.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 48 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Avebonzone, Homosalate, OctisalateAVEBONZONE, HOMOSALATE, OCTISALATEAmazon.com Services LLC4ab6773f-00e1-897a-e063-6294a90ab0b82026-04-06Warnings, Adverse reactionsExact identifier
application number: M020
Principal Secret Revolutionary Anti-Aging Broad Spectrum SPF 15AVOBENZONE, OCTINOXATE, OCTISALATE, AND OCTOCRYLENEGuthy-Renker LLCeb1a9b67-b9e2-41f8-bc6d-df94b6a33ab82026-04-06WarningsExact identifier
application number: M020
TIRTIR HYDRO UV SHIELD SUNSCREEN SPF50 BROAD SPECTRUMHOMOSALATE, AVOBENZONE, OCTISALATE, OCTOCRYLENETIRTIR USA Inc.4ec04105-e54f-a82e-e063-6394a90a6c5a2026-04-05WarningsExact identifier
application number: M020
PRVWORA Ultra Defense SunscreenAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENECellarkbio Inc.50cf1d88-3e7e-47b7-816a-3d579bde0a6a2026-04-04WarningsExact identifier
application number: M020
EltaMD UV Shield SPF45ZINC OXIDE AND OCTINOXATE SUNSCREENCP Skin Health Group, Inc.7c49f971-d425-4be9-a665-5cd218b7f9452026-04-03WarningsExact identifier
application number: M020
Jack BlackAVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUMJack Black L.L.C.4baade5c-e759-d98f-e063-6394a90aa0562026-04-03WarningsExact identifier
application number: M020
Vacation SPF 30 ClassicSprayAVOBENZONE, OCTISALATE, OCTOCRYLENEVacation Inc.da43d71d-733b-5700-e053-2a95a90a5dca2026-04-03WarningsExact identifier
application number: M020
Warriors Crown Sentinel Zinc Defense Sunscreen SPF 30ZINC OXIDEAllure Labs4e93e64a-97ab-e0a5-e063-6294a90ad9502026-04-03WarningsExact identifier
application number: M020
Pro-Collagen Marine Broad Spectrum SPF 30AVOBENZONE, OCTINOXATE, AND OCTOCRYLENEELEMIS Limited3321281e-612b-4305-bf6d-bfab02c65ffb2026-04-03WarningsExact identifier
application number: M020
EltaMD Skincare UV AOX Elements SPF50 TintedTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc2c74209d-9b88-4c32-ad42-cd6de16c1fef2026-04-03WarningsExact identifier
application number: M020
EltaMD UV Restore TintedTITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENCP Skin Health Group, Inc4fc18856-01b3-43ed-9e1b-b4394e31aa3c2026-04-03WarningsExact identifier
application number: M020
Sunscreen for baby SPF50plusOCTOCRYLENE,ETHYLHEXYL METHOXYCINNAMATE,TITANIUM DIOXIDE,ETHYLHEXYL SALICYLATEGuangzhou Senmai Biotechnology Co., Ltd.1cb7fbca-0874-ae53-e063-6294a90ab42a2026-04-02WarningsExact identifier
application number: M020
TiZO3TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD4e7bdec2-abcc-0267-e063-6394a90ae47a2026-04-02WarningsExact identifier
application number: M020
TIZO PHOTOCEUTICAL AM REPLENISH - TINTEDZINC OXIDEFallien Cosmeceuticals, LTD4e7c4702-5707-6c3e-e063-6394a90a05fd2026-04-02WarningsExact identifier
application number: M020
Ilia Sun Serum Mineral Sunscreen SPF 50 Light MediumZINC OXIDEIlia, Inc.4e7cc73c-d6c9-ecb0-e063-6394a90a922c2026-04-02WarningsExact identifier
application number: M020
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc17b47994-82d6-4f9d-8249-bdb55106c9b32026-04-02WarningsExact identifier
application number: M020
Hand Sunscreen CreamAVOBENZONE, OCTISALATE, OCTOCRYLENEJiangsu Senwo Medical Technology Co., Ltd.4e615757-76b1-8f34-e063-6394a90a280a2026-04-01WarningsExact identifier
application number: M020
All Good Mineral Sport Sunscreen Sunstick SPF 30ZINC OXIDEElemental Herbs, Inc.4e67b76e-b791-4e26-e063-6294a90aa9912026-04-01WarningsExact identifier
application number: M020
All Good Coconut Mineral Sunscreen Sunstick SPF 30ZINC OXIDEElemental Herbs, Inc.4e67e89b-a7be-a540-e063-6294a90a6d8f2026-04-01WarningsExact identifier
application number: M020
SHISEIDO BENEFIANCE WRINKLE SMOOTHING DAYAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEShiseido Americas Corporationcad3a446-36a8-4146-81b5-1cc8d65abf142026-04-01WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
49967-212-01499670212011 TUBE in 1 CARTON (49967-212-01) / 50 mL in 1 TUBE1 tube2024-01-11NoNoCurrent
49967-212-024996702120215 TUBE in 1 PACKAGE (49967-212-02) / 5 mL in 1 TUBE15 tube2024-01-11NoNoCurrent