FDA.reportPublic FDA data

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

Product NDC
49967-994
11-digit product format
499670994
Labeler code
49967
Product ID
49967-994_f675b238-84d1-4eb9-b874-78c81ab0173c
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 60 Breakout Free Oil Free Face 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
06f2ced8-273e-454f-92b4-2846f6674b37Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-994-01La Roche Posay Laboratoire Dermatologique Anthelios 60 Breakout Free Oil Free Face Dry Touch Broad Spectrum SPF 60 Sunscreen Water Resistant 80 Minutes50 mL in 1 BOTTLELOTION506
49967-994-01La Roche Posay Laboratoire Dermatologique Anthelios 60 Breakout Free Oil Free Face Dry Touch Broad Spectrum SPF 60 Sunscreen Water Resistant 80 Minutes1 in 1 CARTONLOTION16
49967-994-02La Roche Posay Laboratoire Dermatologique Anthelios 60 Breakout Free Oil Free Face Dry Touch Broad Spectrum SPF 60 Sunscreen Water Resistant 80 Minutes3 mL in 1 PACKETLOTION36
49967-994-03La Roche Posay Laboratoire Dermatologique Anthelios 60 Breakout Free Oil Free Face Dry Touch Broad Spectrum SPF 60 Sunscreen Water Resistant 80 Minutes1 in 1 CARTONLOTION16
49967-994-03La Roche Posay Laboratoire Dermatologique Anthelios 60 Breakout Free Oil Free Face Dry Touch Broad Spectrum SPF 60 Sunscreen Water Resistant 80 Minutes50 mL in 1 TUBELOTION506
49967-994-04La Roche Posay Laboratoire Dermatologique Anthelios 60 Breakout Free Oil Free Face Dry Touch Broad Spectrum SPF 60 Sunscreen Water Resistant 80 Minutes3 mL in 1 TUBELOTION36
49967-994-05La Roche Posay Laboratoire Dermatologique Anthelios 60 Breakout Free Oil Free Face Dry Touch Broad Spectrum SPF 60 Sunscreen Water Resistant 80 Minutes90 mL in 1 TUBELOTION906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-994LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 60 BREAKOUT FREE OIL FREE FACE DRY TOUCH BROAD SPECTRUM SPF 60 SUNSCREEN WATER RESISTANT 80 MINUTES (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) LOTION [L'OREAL USA PRODUCTS INC]5Current NDC, Legacy NDC, 7 package rows20240101_06f2ced8-273e-454f-92b4-2846f6674b37.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 150 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Srubs SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEITW Pro Brands06c1dc42-5a01-f898-e063-6394a90a1a1a2025-12-05WarningsExact identifier
application number: M020
OUHOE Tinted SunscreenTITANIUM DIOXIDEShantou Ouhoe Technology Co., Ltd.4540f542-248d-bcf5-e063-6294a90aabca2025-12-05WarningsExact identifier
application number: M020
No 7 Restore and Renew Multi Action Fragrance Free Day Cream SPF 25AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS45c7703b-7ab4-2ef2-e063-6294a90a2b462025-12-05WarningsExact identifier
application number: M020
No7 Restore and Renew Multi Action Day Cream Sunscreen Broad Spectrum SPF 25AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS4645b051-ef5a-521e-e063-6294a90a24042025-12-05WarningsExact identifier
application number: M020
SPF 50 Mineral Sunscreen bkidsZINC OXIDEKAS Direct LLC dba BabyGanicsf717cd89-194b-42e3-a079-24b2903deb292025-12-05WarningsExact identifier
application number: M020
Sugargirl Set SPF 30 sunscreen shimmer sunscreen mist for the faceHOMOSALATE , OCTOCRYLENE ,OCTISALATE , AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.451b662a-70ed-8ec5-e063-6294a90a005b2025-12-04WarningsExact identifier
application number: M020
Sugargirl SPF 30 sunscreen illuminating stick sunlightHOMOSALATE ,OCTOCRYLENE ,OCTISALATE , AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.451b71a9-2240-853f-e063-6394a90ac8f42025-12-04WarningsExact identifier
application number: M020
Poolside Orange Creme SPF 30 SCENTED gel sunscreenHOMOSALATE,OCTOCRYLENE,OCTISALATE,OCTIONXATE,AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.451b7229-67d1-8b0e-e063-6394a90ab71e2025-12-04WarningsExact identifier
application number: M020
Sugargirl SPF 30 sunscreen illuminating stick solarHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.451b7229-67d3-8b0e-e063-6394a90ab71e2025-12-04WarningsExact identifier
application number: M020
Poolside Sun Silk Body Cream SUNGLOW 05 FRAGRANCE Sunscreen SPF 30 body creamHOMOSALATE, OCTOCRYENE, OCTISALATE, QCTINOXATE, AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.451b86fa-6c1c-a708-e063-6394a90a47a92025-12-04WarningsExact identifier
application number: M020
Poolside Clear Intentions Invisible Face Sunscreen SPF 30HOMOSALATE, OCTOCRYLENE, OCTISALATE,OCTINOXATE, AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.451b902d-892d-15f1-e063-6294a90a30242025-12-04WarningsExact identifier
application number: M020
Sugargirl sun gloss SPF15 tinted lip gloss Sunscreen Vanilla IcingHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.451ba227-7973-1378-e063-6294a90ae8932025-12-04WarningsExact identifier
application number: M020
Sugargirl sun gloss SPF15 tinted lip gloss Sunscreen Pink IceHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.451ba704-6fbd-d5a0-e063-6394a90a2fbc2025-12-04WarningsExact identifier
application number: M020
Sugargirl sun gloss SPF15 tinted lip gloss Sunscreen Tropic TwistHOMOSALATE,OCTOCRYLENE, OCTISALATE, AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.451bb62e-b603-7663-e063-6294a90a46db2025-12-04WarningsExact identifier
application number: M020
Prequel Lip Visor SPF 30 ROSEDUSTLIP 30 CLEARThe Center Brands, LLC33d5e1ad-ba7a-25f8-e063-6294a90aa38e2025-12-04WarningsExact identifier
application number: M020
Resting Beach Face SPF30 Anti-Pollution Sunscreen SerumBUTYL METHOXYDIBENZOYLMETHANE, HOMOSALATE, OCTYL SALICYLATE, OCTOCRYLENEEveryday Group Limted54f8aca8-fbbc-498a-aaf8-aee716511dde2025-12-04WarningsExact identifier
application number: M020
Oh My Bod SPF50 Antioxidant Infused Dry Touch SunscreenBUTYL METHOXYDIBENZOYLMETHANE, HOMOSALATE, OCTOCRYLENE, OCTYL SALICYLATEEveryday Group Limted48e70326-ecf7-44c9-a4cc-2044bd6a64152025-12-04WarningsExact identifier
application number: M020
LIGHTSAVE TRIPLESOME SERUM TINTEDZINC OXIDEReve Skincare LLC35f5652f-3e6b-71c9-e063-6294a90a9e862025-12-04WarningsExact identifier
application number: M020
LIGHTSAVE TRIPLESOME SERUM IVORTYZINC OXIDEReve Skincare LLC35f4dd1b-c3d9-8408-e063-6394a90a79142025-12-04WarningsExact identifier
application number: M020
Activated Mineral Sunscreen TintedACTIVATED MINERAL SUNSCREEN TINTEDReve Skincare LLC312a32a7-d253-f10c-e063-6294a90a803a2025-12-04WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49967-994-01499670994011 BOTTLE in 1 CARTON (49967-994-01) / 50 mL in 1 BOTTLE1 bottle2016-01-010000-00-00NoNoCurrent
49967-994-02499670994023 mL in 1 PACKET (49967-994-02) 3 ml2016-01-010000-00-00NoNoCurrent
49967-994-03499670994031 TUBE in 1 CARTON (49967-994-03) / 50 mL in 1 TUBE1 tube2016-01-010000-00-00NoNoCurrent
49967-994-04499670994043 mL in 1 TUBE (49967-994-04) 3 ml2022-01-14NoNoCurrent
49967-994-054996709940590 mL in 1 TUBE (49967-994-05) 90 ml2023-05-15NoNoCurrent