FDA.reportPublic FDA data

La Roche Posay Laboratoire Dermatologique Anthelios Clear Skin Face Oil Free Dry Touch Broad Spectrum SPF 60 Sunscreen Water Resistant 80 Minutes

Product NDC
49967-048
11-digit product format
499670048
Labeler code
49967
Product ID
49967-048_f3aa7529-2588-4923-a8a3-6734a54b1029
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
2015-01-01
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
30; 150; 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 Clear Skin Face Oil Free Dry Touch Broad Spectrum SPF 60 Sunscreen Water Resistant 80 Minutes
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/mL
HOMOSALATE150 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
e1310453-1880-43a5-982b-cf9b30cfdc47Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-048-01La Roche Posay Laboratoire Dermatologique Anthelios Clear Skin Face Oil Free Dry Touch Broad Spectrum SPF 60 Sunscreen Water Resistant 80 Minutes50 mL in 1 BOTTLELOTION5010
49967-048-01La Roche Posay Laboratoire Dermatologique Anthelios Clear Skin Face Oil Free Dry Touch Broad Spectrum SPF 60 Sunscreen Water Resistant 80 Minutes1 in 1 CARTONLOTION110
49967-048-02La Roche Posay Laboratoire Dermatologique Anthelios Clear Skin Face Oil Free Dry Touch Broad Spectrum SPF 60 Sunscreen Water Resistant 80 Minutes3 mL in 1 PACKETLOTION310
49967-048-03La Roche Posay Laboratoire Dermatologique Anthelios Clear Skin Face Oil Free Dry Touch Broad Spectrum SPF 60 Sunscreen Water Resistant 80 Minutes1 in 1 CARTONLOTION110
49967-048-03La Roche Posay Laboratoire Dermatologique Anthelios Clear Skin Face Oil Free Dry Touch Broad Spectrum SPF 60 Sunscreen Water Resistant 80 Minutes50 mL in 1 TUBELOTION5010
49967-048-04La Roche Posay Laboratoire Dermatologique Anthelios Clear Skin Face Oil Free Dry Touch Broad Spectrum SPF 60 Sunscreen Water Resistant 80 Minutes3 mL in 1 TUBELOTION310
49967-048-04La Roche Posay Laboratoire Dermatologique Anthelios Clear Skin Face Oil Free Dry Touch Broad Spectrum SPF 60 Sunscreen Water Resistant 80 Minutes1 in 1 CARTONLOTION110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-048LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS CLEAR SKIN FACE OIL FREE DRY TOUCH BROAD SPECTRUM SPF 60 SUNSCREEN WATER RESISTANT 80 MINUTES (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) LOTION [L'OREAL USA PRODUCTS INC]10Current NDC, Legacy NDC, 7 package rows20240102_e1310453-1880-43a5-982b-cf9b30cfdc47.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 244 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Refreshing Water Hydration Stick SPF 50AVOBENZONE OCTISALATE HOMOSALATE OCTOCRYLENECOOLA LLC6da037f8-bedb-467a-b534-e44752120f2c2024-12-27WarningsExact identifier
application number: M020
Nu Skin ageLOC Radiant Day Broad Spectrum SPF 22AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENENSE Products, Inc.649a9c28-bfd4-404c-90d5-5d0ea8c7b6452024-12-27WarningsExact identifier
application number: M020
Kiehls Since 1851 Activated Sun Protector For Face and Body Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDEL'Oreal USA Products Inc87496037-36ca-4c5f-973f-46626cf4096e2024-12-27WarningsExact identifier
application number: M020
PORESCREEN SPF40ZINC OXIDEDermalogica, LLC.37a7362a-b251-4d3a-a957-65d8f338fa122024-12-27WarningsExact identifier
application number: M020
COOLA Classic Face Sunscreen Fragrance-Free SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA LLC12ff4689-f7e2-49db-8848-608c61b41ef02024-12-27WarningsExact identifier
application number: M020
NUDESCREEN LIP PRIMER SPF 30 - NATURAL TINTZINC OXIDEBentley Laboratories, LLC6edd51e5-1c42-4e66-b5ca-abfea2dad8f82024-12-27WarningsExact identifier
application number: M020
Tone Control Morning Cream SPF 15OCTOCRYLENE AND OCTISALATE CREAMBentley Laboratories, LLCb4e3cd1c-ae42-4995-a314-96d24d328e412024-12-27WarningsExact identifier
application number: M020
ZO Skin Health Sunscreen Plus Powder Broad-Spectrum SPF 45 (Light)ZINC OXIDEZO Skin Health, Inc.be25489e-c3bf-77c5-e053-2a95a90a30de2024-12-27WarningsExact identifier
application number: M020
COOLA Classic Body Sunscreen Tropical Coconut SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA LLC55ad5d2f-a855-491e-a287-13689f8abff12024-12-27WarningsExact identifier
application number: M020
RODAN and FIELDS UNBLEMISHTITANIUM DIOXIDE, ZINC OXIDEBentley Laboratories, LLC2b3b6b62-364f-4aba-8024-3a73752b4c562024-12-27WarningsExact identifier
application number: M020
Powerbright Moisturizer SPF 50OCTOCRYLENE, HOMOSALATE, AVOBENZONE, AND OCTISALATEDermalogica, LLC.02c731ee-c5cb-4158-9b1f-e826593c35262024-12-27WarningsExact identifier
application number: M020
INVISIBLE PHYSICAL DEFENSE SPF30ZINC OXIDEDermalogica, Inc.2e5e6861-25ea-4605-8e59-41d852c002b72024-12-27WarningsExact identifier
application number: M020
COOLA CLASSIC FACE SUNSCREEN Cucumber Broad Spectrum SPF 30AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENECOOLA LLCdec3b0d1-f06e-4acf-8ba2-64167e774abc2024-12-27WarningsExact identifier
application number: M020
Clearing Defense SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEDermalogica, Inc.2388ae53-0a61-43c0-8936-c639887a56492024-12-26WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c5efde-42e3-e4fc-e063-6394a90a491d2024-12-26WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c62206-d832-8d9a-e063-6394a90a4c692024-12-26WarningsExact identifier
application number: M020
Morphe SPF 30 Broad Spectrum Sunsetter SettingOCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATECOSMAX USA, CORPORATION0d34406f-9dd0-3909-e063-6394a90ab9f92024-12-26WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c64cc0-be42-c210-e063-6394a90a6d9a2024-12-26WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c61c42-edda-1ebd-e063-6294a90aee132024-12-26WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c62206-d839-8d9a-e063-6394a90a4c692024-12-26WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49967-048-01499670048011 BOTTLE in 1 CARTON (49967-048-01) / 50 mL in 1 BOTTLE1 bottle2016-01-010000-00-00NoNoCurrent
49967-048-02499670048023 mL in 1 PACKET (49967-048-02) 3 ml2016-01-010000-00-00NoNoCurrent
49967-048-03499670048031 TUBE in 1 CARTON (49967-048-03) / 50 mL in 1 TUBE1 tube2016-01-010000-00-00NoNoCurrent
49967-048-04499670048041 TUBE in 1 CARTON (49967-048-04) / 3 mL in 1 TUBE1 tube2016-01-010000-00-00NoNoCurrent