LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS KIDS GENTLE BROAD SPECTRUM SPF 50 SUNSCREEN FOR FACE AND BODY WATER RESISTANT 80 MINUTES- avobenzone, homosalate, octisalate and octocrylene lotion 
L'Oreal USA Products Inc

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Drug Facts

Active ingredient

Avobenzone 3%

Homosalate 13%

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, dimethicone, glycerin, styrene/acrylates copolymer, poly c10-30 alkyl acrylate, polymethylsilsesquioxane, acrylates/dimethicone copolymer, niacinamide, silica, caprylyl methicone, acrylates/c10-30 alkyl acrylate crosspolymer, caprylic/capric triglyceride, caprylyl glycol, chlorphenesin, diethylhexyl syringylidenemalonate, glyceryl stearate, inulin lauryl carbamate, p-anisic acid, panthenol, PEG-100 stearate, PEG-8 laurate, phenoxyethanol, potassium cetyl phosphate, sodium dodecylbenzenesulfonate, sodium hyaluronate, tocopherol, triethanolamine, trisodium ethylenediamine disuccinate, xanthan gum

Questions or comments?

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

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

image of a label

image of a label
LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS KIDS GENTLE BROAD SPECTRUM SPF 50 SUNSCREEN FOR FACE AND BODY WATER RESISTANT 80 MINUTES 
avobenzone, homosalate, octisalate and octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-603
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) HOMOSALATE130 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERIN (UNII: PDC6A3C0OX)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
NIACINAMIDE (UNII: 25X51I8RD4)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
GLYCERYL DISTEARATE (UNII: 73071MW2KM)  
INULIN LAURYL CARBAMATE (UNII: 48RFF58ESG)  
P-ANISIC ACID (UNII: 4SB6Y7DMM3)  
PANTHENOL (UNII: WV9CM0O67Z)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PEG-8 LAURATE (UNII: 762O8IWA10)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TROLAMINE (UNII: 9O3K93S3TK)  
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-603-01200 mL in 1 TUBE; Type 0: Not a Combination Product10/01/2022
2NDC:49967-603-025 mL in 1 TUBE; Type 0: Not a Combination Product10/01/2022
3NDC:49967-603-032 mL in 1 PACKET; Type 0: Not a Combination Product10/01/2022
4NDC:49967-603-041 in 1 CARTON10/01/2022
415 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02010/01/2022
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
L'Oreal USA, Inc.185931458manufacture(49967-603) , pack(49967-603)

Revised: 12/2023
 
L'Oreal USA Products Inc