Label: HYDRATING SPF 30- avobenzone 3% homosalate 15% octisalate 5% octocrylene 8% spray
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Contains inactivated NDC Code(s)
NDC Code(s): 0363-1123-05, 0363-1123-06 - Packager: Walgreens
- 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 April 27, 2018
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active ingredients Purpose
Avobenzone 3%.................................................................Sunscreen
Homosalate 15%...............................................................Sunscreen
Octisalate 5%....................................................................Sunscreen
Octocrylene 8%.................................................................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 out of eyes. Rinse with water to remove.
Stop use and ask a doctor if • rash or irritation develops and lastAvoid spraying in eyes. Contents under pressure. Do not puncture or
incinerate. Do not store at temperature above 120°F - KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions • Apply liberally 15 minutes before sun exposure and
as needed. • 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. • 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.
• For sunscreen use: • apply to all skin exposed to the sun. • Reapply as
needed or after towel drying, swimming, or sweating - OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- Questions?1-800-925-4733
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HYDRATING SPF 30
avobenzone 3% homosalate 15% octisalate 5% octocrylene 8% sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-1123 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 8 g in 100 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) ALOE VERA LEAF (UNII: ZY81Z83H0X) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) Diethylhexyl Syringylidenemalonate (UNII: 3V5U97P248) Glycerin (UNII: PDC6A3C0OX) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) Stearoxytrimethylsilane (UNII: 9862TW94B2) Tocopherol (UNII: R0ZB2556P8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-1123-05 156 g in 1 CAN; Type 0: Not a Combination Product 11/16/2016 2 NDC:0363-1123-06 283 g in 1 CAN; Type 0: Not a Combination Product 11/16/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/16/2016 Labeler - Walgreens (008965063) Registrant - Product Quiest Mfg (927768135) Establishment Name Address ID/FEI Business Operations Product Quiest Mfg 927768135 manufacture(0363-1123) , label(0363-1123)