FDA.reportPublic FDA data

La Roche Posay Face Body Anthelios SPF 60 Melt In Milk Fast absorbing, velvety finish for all skin types with Cell-OC Shield XL

Product NDC
49967-355
11-digit product format
499670355
Labeler code
49967
Product ID
49967-355_a2e6de63-3afd-48ed-a639-a3d981f354a2
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
2018-12-15
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
30; 100; 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 Face Body Anthelios SPF 60 Melt In Milk Fast absorbing, velvety finish for all skin types with Cell-OC Shield XL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/mL
HOMOSALATE100 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
533e6623-108e-4d05-8527-c5af643f0800Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-355-01La Roche Posay Face Body Anthelios SPF 60 Melt In Milk Fast absorbing, velvety finish for all skin types with Cell-OC Shield XL90 mL in 1 TUBElotion908
49967-355-01La Roche Posay Face Body Anthelios SPF 60 Melt In Milk Fast absorbing, velvety finish for all skin types with Cell-OC Shield XL1 in 1 CARTONlotion18
49967-355-02La Roche Posay Face Body Anthelios SPF 60 Melt In Milk Fast absorbing, velvety finish for all skin types with Cell-OC Shield XL2 mL in 1 PACKETlotion28
49967-355-03La Roche Posay Face Body Anthelios SPF 60 Melt In Milk Fast absorbing, velvety finish for all skin types with Cell-OC Shield XL50 mL in 1 TUBElotion508
49967-355-03La Roche Posay Face Body Anthelios SPF 60 Melt In Milk Fast absorbing, velvety finish for all skin types with Cell-OC Shield XL1 in 1 CARTONlotion18
49967-355-04La Roche Posay Face Body Anthelios SPF 60 Melt In Milk Fast absorbing, velvety finish for all skin types with Cell-OC Shield XL1 in 1 CARTONlotion18
49967-355-04La Roche Posay Face Body Anthelios SPF 60 Melt In Milk Fast absorbing, velvety finish for all skin types with Cell-OC Shield XL150 mL in 1 TUBElotion1508
49967-355-05La Roche Posay Face Body Anthelios SPF 60 Melt In Milk Fast absorbing, velvety finish for all skin types with Cell-OC Shield XL15 mL in 1 TUBElotion158
49967-355-06La Roche Posay Face Body Anthelios SPF 60 Melt In Milk Fast absorbing, velvety finish for all skin types with Cell-OC Shield XL1000 mL in 1 BOTTLElotion10008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-355LA ROCHE POSAY FACE BODY ANTHELIOS SPF 60 MELT IN MILK FAST ABSORBING, VELVETY FINISH FOR ALL SKIN TYPES WITH CELL-OC SHIELD XL (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) LOTION [L'OREAL USA PRODUCTS INC]8Current NDC, Legacy NDC, 9 package rows20240101_533e6623-108e-4d05-8527-c5af643f0800.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 183 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HAWAIIAN TROPICAVOBENZONE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC053e76f0-8ca0-645d-e063-6394a90a01d22025-09-28WarningsExact identifier
application number: M020
Hawaiian Tropic Mineral Translucent Sunscreen Powder SPF 30ZINC OXIDEEdgewell Personal Care Brands LLCcdc54f23-0efb-2fb4-e053-2995a90ae58b2025-09-28WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC0540017a-52ac-7972-e063-6394a90a139c2025-09-28WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC08f3b27f-b233-d406-e063-6394a90ada762025-09-28WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC128a3772-b9b7-0d10-e063-6294a90a3e052025-09-28WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC203c82a2-0131-8023-e063-6294a90aba7b2025-09-28WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC203c780a-3107-d71a-e063-6394a90aca252025-09-28WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC31d01fae-4085-d84a-e063-6294a90ab9812025-09-28WarningsExact identifier
application number: M020
Hawaiian TropicAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands, LLC3388c2fa-8082-95d4-e063-6294a90a94b82025-09-28WarningsExact identifier
application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEKenvue Brands LLCb10a7794-7e4f-412b-9eb2-773107ecb7fc2025-09-26WarningsExact identifier
application number: M020
Black Girl Sunscreen SPF 50HOMOSALATE 10.00% OCTOCRYLENE 10.00% OCTISALATE 5.00% AVOBENZONE 3.00%Black Girl Sunscreenfed22570-e0ae-43e1-b6ce-1f0ad01684c32025-09-26WarningsExact identifier
application number: M020
Smooth Even GlowTINTED SUNSCREEN BROAD SPF30SKNVcare, LLC3fa48151-fcb9-3d35-e063-6394a90a2eb62025-09-25WarningsExact identifier
application number: M020
CHEEK CREME BROAD SPECTRUM SPF 30 SUNSCREEN BLUSH HEAT WAVEAVOBENZONE, HOMOSALATE, OCTISALATEMDSolarSciences3fa810b0-0211-f2a7-e063-6294a90a0b722025-09-25WarningsExact identifier
application number: M020
SUN BUFF SPF 30 MINERAL SUNSCREENZINC OXIDE/TITANIUM DIOXIDESPF Ventures, LLC3f874062-ebab-8993-e063-6294a90abfc52025-09-24WarningsExact identifier
application number: M020
HygieneLab Face and Body Mineral Sunscreen SPF 50ZINC OXIDEHYGIENELAB, INC7db103da-b434-433a-a18f-a727165640c02025-09-24WarningsExact identifier
application number: M020
Eve Lom Daily Protection Broad Spectrum SPF 50 SunscreenHOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONE, OCTINOXATE AND OCTOCRYLENESpace Brands Limited0e2c9ffb-036d-49c5-abdb-2ee8888df3182025-09-24WarningsExact identifier
application number: M020
PUR 4-in-1 Skin Tint DG6ZINC OXIDEPUR Minerals3f8e97a7-2023-ba9c-e063-6294a90ac9c92025-09-24WarningsExact identifier
application number: M020
PUR 4-in-1 Skin Tint TN7ZINC OXIDEPUR Minerals3f0717c7-f43f-e3b1-e063-6394a90a74dd2025-09-24WarningsExact identifier
application number: M020
PUR 4-in-1 Skin Tint TN2ZINC OXIDEPUR Minerals3f06ed2f-f43f-53d4-e063-6294a90af0dd2025-09-24WarningsExact identifier
application number: M020
PUR 4-in-1 Skin Tint MN4ZINC OXIDEPUR Minerals3f06f618-f7b2-53d0-e063-6294a90a829c2025-09-24WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49967-355-01499670355011 TUBE in 1 CARTON (49967-355-01) / 90 mL in 1 TUBE1 tube2018-12-150000-00-00NoNoCurrent
49967-355-02499670355022 mL in 1 PACKET (49967-355-02) 2 ml2019-04-010000-00-00NoNoCurrent
49967-355-03499670355031 TUBE in 1 CARTON (49967-355-03) / 50 mL in 1 TUBE1 tube2018-12-150000-00-00NoNoCurrent
49967-355-04499670355041 TUBE in 1 CARTON (49967-355-04) / 150 mL in 1 TUBE1 tube2019-04-010000-00-00NoNoCurrent
49967-355-054996703550515 mL in 1 TUBE (49967-355-05) 15 ml2018-12-150000-00-00NoNoCurrent
49967-355-06499670355061000 mL in 1 BOTTLE (49967-355-06) 1000 ml2018-12-150000-00-00NoNoCurrent