LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE SPORT ANTHELIOS ACTIVEWEAR BROAD SPECTRUM SPF 60 SUNSCREEN- avobenzone, homosalate, octisalate and octocrylene lotion 
L'Oreal USA Products Inc

----------

Drug Facts

Active ingredients

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 7%

Purpose

Sunscreen

Uses

Warnings

For external use only

Do not use

on damaged or broken skin

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

rash occurs

Keep out of reach of children.

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

Directions

Other information

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

Inactive ingredients

water, silica, dicaprylyl carbonate, styrene/acrylates copolymer, butyloctyl salicylate, menthyl methacrylae crosspolymer, nylon-12, PEG-100, glyceryl stearate, perlite, beeswax, ammonium poolyacrylloyldiimethy taurate, behenyl alcohol, caprylic/capric triglyceride, cassia alata leaf extract, chlorphenesisn, diethylhexyl syringlyidenemalonate, disodium EDTA, maltodextrin, p-anisic acid, PEG-8 laurate, phenoxethanol, propylene glycol, sodium stearoyl glutamate, tocopherol, xanthan gum

Questions or comments?

1-888-577-5226 Monday - Friday (9 a.m. - 5 p.m. EST)

image description

image description
LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE SPORT ANTHELIOS ACTIVEWEAR BROAD SPECTRUM SPF 60 SUNSCREEN 
avobenzone, homosalate, octisalate and octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-431
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE150 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE70 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
NYLON-12 (UNII: 446U8J075B)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
PERLITE (UNII: 0SG101ZGK9)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
PEG-8 LAURATE (UNII: 762O8IWA10)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
TOCOPHEROL (UNII: R0ZB2556P8)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-431-01150 mL in 1 BOTTLE; Type 0: Not a Combination Product10/17/2017
2NDC:49967-431-025 mL in 1 PACKET; Type 0: Not a Combination Product10/17/2017
3NDC:49967-431-03150 mL in 1 TUBE; Type 0: Not a Combination Product10/17/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02010/17/2017
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
L'Oreal USA, Inc.185931458manufacture(49967-431)

Revised: 12/2023
Document Id: 2b9f3cfc-931f-4c9e-b9bd-d2e6a93fd88c
Set id: 071bfb80-d980-4e62-9cd6-96149f1ba04a
Version: 6
Effective Time: 20231231
 
L'Oreal USA Products Inc