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ACTIVE INGREDIENT
Active ingredients Purpose
Avobenzone 3%.................................................................................Sunscreen
Homosalate 15%................................................................................Sunscreen
Octisalate 5%....................................................................................Sunscreen
Octocrylene 10%...............................................................................Sunscreen - PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings
Flammable: Do not use near heat, flame, or while smoking.
For external use only
Do not use on damaged or broken skin
When using this product keep away from face to avoid breathing it • keep
out of eyes. Rinse eyes with water to remove.
Stop use and ask a doctor if • rash occurs.
Keep out of reach of children. If product is swallowed, get medical help or
contact a Poison Control Center right away.
Avoid spraying in eyes. • Contents under pressure. Do not puncture or
incinerate. • Do not store at temperatures above 120ºF - KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions • Spray liberally and spread evenly by hand 15 minutes
before sun exposure • Reapply: • after 80 minutes of swimming or sweating •
immediately after towel drying • at least every 2 hours • Hold container 4 to 6
inches from the skin to apply • Do not spray directly into face. Spray on hands
then apply to face. • Do not apply in windy conditions • Use in a well-ventilated
area • Children under 6 months: ask a doctor • 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-sleeve shirts,
pants, hats, and sunglasses - OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SUNSCREEN SPF 70
avobenzone 3% homosalate 15% octisalate 5% octocrylene 10% sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:47124-115 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone 3 g in 100 g Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate 15 g in 100 g Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate 5 g in 100 g Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene 10 g in 100 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) Butyloctyl Salicylate (UNII: 2EH13UN8D3) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) Diethylhexyl Syringylidenemalonate (UNII: 3V5U97P248) Glycerin (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47124-115-05 170 g in 1 CAN; Type 0: Not a Combination Product 03/06/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/06/2013 Labeler - Wegman (059650069) Registrant - Product Quest Mfg (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg 927768135 manufacture(47124-115) , label(47124-115)