Label: AVON SUN SPORT REFRESH SUNSCREEN- homosalate, octinoxate, oxybenzone, octisalate, avobenzone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 10096-0315-1 - Packager: New Avon LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 February 19, 2016
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions
• apply generously and evenly 15 minutes before sun exposure• Rub in until color fades completely.
• children under 6 months of age: ask a doctor
• 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 - STORAGE AND HANDLING
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INACTIVE INGREDIENT
Inactive Ingredients:
WATER/EAU, BUTYLOCTYL SALICYLATE, BUTYLENE GLYCOL, GLYCERIN, PEG-8, POLYESTER-7, NEOPENTYL GLYCOL DIHEPTANOATE, DIMETHICONE, CAPRYLYL GLYCOL, PHENOXYETHANOL, TRIMETHYLSILOXYSILICATE, CHOLESTEROL, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, TROMETHAMINE, HYDROGENATED LECITHIN, PROPYLENE GLYCOL, HEXYLENE GLYCOL, PANTHENOL, PHOSPHATIDYLCHOLINE, PYRUS MALUS (APPLE) FRUIT EXTRACT, ALOE BARBADENSIS LEAF EXTRACT, TOCOPHERYL ACETATE, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, BLUE 1/CI 42090, YELLOW 5/CI 19140 . - QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
AVON SUN SPORT REFRESH SUNSCREEN
homosalate, octinoxate, oxybenzone, octisalate, avobenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10096-0315 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 80 mg in 1 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 60 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10096-0315-1 236 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 12/12/2013 Labeler - New Avon LLC (080143520) Establishment Name Address ID/FEI Business Operations Avon Products, Inc 005149471 manufacture(10096-0315)
