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Drug Facts

Manufacturer
L'Oreal USA Products Inc | L'OREAL USA, INC.
Effective date
2023-12-31
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:06:13

Label at a glance#

ProductLa Roche Posay Face Body Anthelios SPF 60 Melt In Milk Fast absorbing, velvety finish for all skin types with Cell-OC...
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure13 sections

Indications and uses

helps prevent sunburn if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

For sunscreen use: • apply generously 15 minutes before sun exposure • reapply: •    after 80 minutes of swimming or sweating •    immediately after towel drying •    at least every 2 hours • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protect...

Storage and handling

protect the product in this container from excessive heat and direct sun

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 7%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warning

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

For sunscreen use:
• apply generously 15 minutes before sun exposure
• reapply:
•    after 80 minutes of swimming or sweating
•    immediately after towel drying
•    at least every 2 hours
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
•    limit time in the sun, especially from 10 a.m - 2 p.m.
•    wear long-sleeved shirts, pants, hats and sunglasses
•    children under 6 months of age: Ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • protect the product in this container from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, sytrene/acrylates copolymer, dimethicone, polymethlysilsesquioxane, butylocytyl salicylate, glycerin, alcohol denat., poly C10-30 alkyl acrylate, caprylyl methicone, trisiloxane, acrylates/dimethicone copolymer, diethylhexyl syringylidenemalonate, PEG-100 stearate, glyceryl stearate, phenoxyethanol, potassium cetyl phosphate, propylene glycol, caprylyl glycol, PEG-8 laurate, acrylates/C10-30 alkyl acrylate crosspolymer, triethanolamine, tocopherol, inulin lauryl carbamate, disodium EDTA, p-anisic acid, caprylic/capric triglyceride, xanthan gum, cassia alata leaf extract, maltodextrin

Questions or comments?

OTC - QUESTIONS SECTION

1-888-LRP LABO 1-888-577-5226

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of a cartonimage of a carton

image of a carton
image of a carton

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-35549967-355-01, 49967-355-02, 49967-355-03, 49967-355-04, 49967-355-05, 49967-355-06

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
WATER059QF0KO0RIACT
DIMETHICONE92RU3N3Y1OIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
GLYCERINPDC6A3C0OXIACT
ALCOHOL3K9958V90MIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
TRISILANE1T3A75Z4ZLIACT
DIETHYLHEXYL SYRINGYLIDENEMALONATE3V5U97P248IACT
PEG-100 STEARATEYD01N1999RIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PHENOXYETHANOLHIE492ZZ3TIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CAPRYLYL GLYCOL00YIU5438UIACT
PEG-8 LAURATE762O8IWA10IACT
TROLAMINE9O3K93S3TKIACT
TOCOPHEROLR0ZB2556P8IACT
EDETATE DISODIUM7FLD91C86KIACT
P-ANISIC ACID4SB6Y7DMM3IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
XANTHAN GUMTTV12P4NEEIACT
SENNA ALATA LEAF4BXR6YZN92IACT
MALTODEXTRIN7CVR7L4A2DIACT

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
La Roche Posay Face Body Anthelios SPF 60 Melt In Milk Fast absorbing, velvety finish for all skin types with Cell-OC Shield XLAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc533e6623-108e-4d05-8527-c5af643f08002023-12-31WarningsExact identifier
ndc (package): 49967-355-05
ndc (package): 49967-355-03
ndc (package): 49967-355-01
ndc (package): 49967-355-06
ndc (package): 49967-355-02
ndc (package): 49967-355-04
ndc (product): 49967-355
ndc11 (package): 49967035506
ndc11 (package): 49967035502
ndc11 (package): 49967035504
ndc11 (package): 49967035505
ndc11 (package): 49967035503
ndc11 (package): 49967035501
spl id: a2e6de63-3afd-48ed-a639-a3d981f354a2
spl set id: 533e6623-108e-4d05-8527-c5af643f0800

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.