Label: AVON SUN SUNSCREEN- homosalate, octinoxate, octisalate, oxybenzone, avobenzone, octocrylene aerosol, spray
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Contains inactivated NDC Code(s)
NDC Code(s): 10096-0296-1 - 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 17, 2016
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
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WARNINGS
Warnings
For external use onlyDo not use on damaged or broken skin
When using this product
- keep out of eyes. Rinse with water to remove.
- keep away from face to avoid breathing it.
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.
Flammable, contents under pressure. Keep away from flame, fire or extreme heat. Do not place in hot water or near radiators, stove, or other sources of heat. Do not use in presence of open flame or sparks. Do not store at temparatures above 120F (50C). Do not tamper with valve closure or puncture or incinerate can.
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DOSAGE & ADMINISTRATION
Directions
• spray generously and spread evenly by hand 15 minutes before sun exposure• hold container 4 to 6 inches from skin to apply
• do not spray directly into face
• Spray on hands, then apply to face
• do not apply in windy conditions
• use in well-ventilated areas
• 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:
SD ALCOHOL 40-B, C12-15 ALKYL BENZOATE, PPG-2 MYRISTYL ETHER PROPIONATE, DIMETHICONE, GLYCERIN, ACRYLATES/OCTYLACRYLAMIDE COPOLYMER, POLYESTER-8, DILAURYL THIODIPROPIONATE, KAEMPFERIA GALANGA ROOT EXTRACT, GLYCINE SOJA (SOYBEAN) SEED EXTRACT,
PHAEODACTYLUM TRICORNUTUM EXTRACT, ORYZANOL, FOENICULUM VULGARE (FENNEL) FRUIT EXTRACT, DAUCUS CAROTA SATIVA (CARROT) ROOT EXTRACT, TOCOPHEROL, CAPRYLIC/CAPRIC TRIGLYCERIDE, CAPRYLYL GLYCOL, PARFUM/FRAGRANCE, WATER/EAU - QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
AVON SUN SUNSCREEN
homosalate, octinoxate, octisalate, oxybenzone, avobenzone, octocrylene aerosol, sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10096-0296 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 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 47.5 mg in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 47.5 mg in 1 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 28.5 mg in 1 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 25.6 mg in 1 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10096-0296-1 136.5 g in 1 BOTTLE, SPRAY; 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 03/26/2013 Labeler - New Avon LLC (080143520) Establishment Name Address ID/FEI Business Operations Accra Pac, Inc. 024213616 manufacture(10096-0296)
