Label: SUNSCREEN- avobenzon, homosalate,octisalate,octocrylene lotion
- NDC Code(s): 55910-929-34
- Packager: Old East Main Co
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated March 11, 2022
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- use
- Warnings
- Do not use
- Stop use and ask a doctor if
- Keep out of reach of children
-
Directions
- apply liberaly {and evenly} 15 minuts 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 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, aluminum starch octenylsuccinate, styrene/acrylates copolymer, glycerin, polyester-7, silica, chlorphenesin, arachidyl alcohol, beeswax, benzyl alcohol, neopentyl glycol diheptanoate, acrylates/C10-30 alkyl acrylate crosspolymer, behenyl alcohol, tocopherol, arachidyl glucoside, glyceryl stearate, PEG-100 stearate, potassium hydroxide, disodium EDTA, sodium ascorbyl phosphate, fragrance
- other information
- Adverse reactions
- disclaimer
- principal display panel
-
INGREDIENTS AND APPEARANCE
SUNSCREEN
avobenzon, homosalate,octisalate,octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-929 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 90 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 1000 min in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 202.5 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 640 mg in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A) GLYCERIN (UNII: PDC6A3C0OX) POLYESTER-7 (UNII: 0841698D2F) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CHLORPHENESIN (UNII: I670DAL4SZ) arachidyl alcohol (UNII: 1QR1QRA9BU) YELLOW WAX (UNII: 2ZA36H0S2V) BENZYL ALCOHOL (UNII: LKG8494WBH) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) DOCOSANOL (UNII: 9G1OE216XY) TOCOPHEROL (UNII: R0ZB2556P8) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55910-929-34 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/05/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 08/05/2019 Labeler - Old East Main Co (068331990) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(55910-929) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(55910-929)
