LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS BROAD SPECTRUM SPF 100 BODY AND FACE MELT IN MILK SUNSCREEN WATER RESISTANT 80 MINUTES- avobenzone, homosalate, octisalate and octocrylene lotion 
L'Oreal USA Products Inc

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Drug Facts

Active ingredients

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 10%

Purpose

Sunscreen

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

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

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

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

Inactive ingredients

water, polymethylsilsesquioxane, glycerin, dimethicone, poly c10-30 alkyl acrylate, styrene/acrylates copolymer, silica, caprylyl methicone, acrylates/dimethicone copolymer, diethylhexyl syringylidenemalonate, PEG-100 stearate, glyceryl stearate, phenoxyethanol, potassium cetyl phosphate, tocopherol, caprylyl glycol, panthenol, acrylates/c10-30 alkyl acrylate crosspolymer, triethanolamine, PEG-8 laurate, inulin lauryl carbamate, chlorphenesin, p-anisic acid, caprylic/capric triglyceride, xanthan gum, disodium EDTA, cassia alata leaf extract, maltodextrine, sodium dodecylbenzenesulfonate

Questions or comments?

1-888-LRP-LAB0 1-888-577-5226

Monday - Friday (9 a.m. - 5 p.m. EST)

image of a carton

image of a carton
LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS BROAD SPECTRUM SPF 100 BODY AND FACE MELT IN MILK SUNSCREEN WATER RESISTANT 80 MINUTES 
avobenzone, homosalate, octisalate and octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-103
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) OCTOCRYLENE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
PEG-100 STEARATE (UNII: YD01N1999R)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
TOCOPHEROL (UNII: R0ZB2556P8)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
PANTHENOL (UNII: WV9CM0O67Z)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
TROLAMINE (UNII: 9O3K93S3TK)  
PEG-8 LAURATE (UNII: 762O8IWA10)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
P-ANISIC ACID (UNII: 4SB6Y7DMM3)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
XANTHAN GUM (UNII: TTV12P4NEE)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SENNA ALATA LEAF (UNII: 4BXR6YZN92)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-103-011 in 1 CARTON06/01/2020
190 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:49967-103-021 in 1 CARTON06/01/2020
25 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02006/01/2020
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
L'OREAL USA PRODUCTS, INC.624244349manufacture(49967-103) , pack(49967-103)

Revised: 12/2023
Document Id: f9d2a328-c72e-4146-8d04-a199a1a3ed6b
Set id: 511f6de9-264a-4cf2-97c3-aa8adbc52a87
Version: 3
Effective Time: 20231228
 
L'Oreal USA Products Inc