Label: SUNSCREEN FOR BABIES SPF 50- avobenzone, homosalate, octisalate lotion
- NDC Code(s): 72476-947-34
- Packager: Retail Business Services, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 19, 2023
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
-
Directions
- apply liberaly 15 minutes before sun exposure
- apply to all skin exposed to the sun
- 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 rist, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
- limit time in the sun, especialy 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, diethylhexyl 2,6-naphthalate, butyloctyl salicylate, styrene/acrylates copolymer, aluminum starch octenylsuccinate, Aloe barbadensis leaf juice, glycerin, polyester-7, silica, chlorphenesin, benzyl alcohol, arachidyl alcohol, acrylates/C10-30 alkyl acrylate crosspolymer, neopentyl glycol diheptanoate, behenyl alcohol, tocopherol, beeswax, arachidyl glucoside, potassium hydroxide, glyceryl stearate, PEG-100 stearate, disodium EDTA, sodium ascorbyl phosphate, fragrance, hexyl cinnamal, alpha-isomethyl ionone, geraniol
- Adverse Reaction
- Disclaimer
- Principal Panel Display
-
INGREDIENTS AND APPEARANCE
SUNSCREEN FOR BABIES SPF 50
avobenzone, homosalate, octisalate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72476-947 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 120 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) ALOE VERA LEAF (UNII: ZY81Z83H0X) GLYCERIN (UNII: PDC6A3C0OX) POLYESTER-7 (UNII: 0841698D2F) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CHLORPHENESIN (UNII: I670DAL4SZ) BENZYL ALCOHOL (UNII: LKG8494WBH) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) DOCOSANOL (UNII: 9G1OE216XY) TOCOPHEROL (UNII: R0ZB2556P8) YELLOW WAX (UNII: 2ZA36H0S2V) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B) GERANIOL (UNII: L837108USY) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72476-947-34 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/19/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 12/19/2023 Labeler - Retail Business Services, LLC (967989935) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon. LLC 790752542 manufacture(72476-947) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(72476-947)
