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
-
NDC Code(s):
49967-603-01,
49967-603-02,
49967-603-03,
49967-603-04, view more49967-603-05
- Packager: L'Oreal USA Products Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 1, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
-
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
-
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?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
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 lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-603 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 130 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 100 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:49967-603-01 200 mL in 1 TUBE; Type 0: Not a Combination Product 10/01/2022 2 NDC:49967-603-02 5 mL in 1 TUBE; Type 0: Not a Combination Product 10/01/2022 3 NDC:49967-603-03 2 mL in 1 PACKET; Type 0: Not a Combination Product 10/01/2022 4 NDC:49967-603-04 1 in 1 CARTON 10/01/2022 4 15 mL in 1 TUBE; Type 0: Not a Combination Product 5 NDC:49967-603-05 1 in 1 CARTON 10/01/2022 5 90 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 10/01/2022 Labeler - L'Oreal USA Products Inc (002136794) Establishment Name Address ID/FEI Business Operations L'Oreal USA, Inc. 185931458 manufacture(49967-603) , pack(49967-603)
