NDC | 55910-777-05 |
Set ID | bc1b1a10-f1f0-4eeb-9c7d-a75047939285 |
Category | HUMAN OTC DRUG LABEL |
Packager | Dollar General |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
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ACTIVE INGREDIENT
Active ingredients Purpose
Avobenzone 2.00%........................................................................Sunscreen
Homosalate 10.00%.......................................................................Sunscreen
Octisalate 5.00%............................................................................Sunscreen
Oxybenzone 3.00%........................................................................Sunscreen - PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings
For external use only
Flammable: Do not use near heat, flame, or while smoking.
Do not use on damaged or broken skin
When using this product • Keep out of eyes. Rinse eyes with water to remove.
• Keep away from face to avoid breathing it • Do not puncture or incinerate.
Contents under pressure. Do not store at temperatures above 120ºF.
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. -
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
• 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 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
• children under 6 months: Ask a doctor - OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TANNING DRY OIL SPF 15 DOLLAR GENERAL
avobenzone 2.00% homosalate 10.00% octisalate 5.00% oxybenzone 3.00% sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-777 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone 2 g in 100 mL Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate 10 g in 100 mL Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate 5 g in 100 mL Oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) Oxybenzone 3 g in 100 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) ALOE VERA LEAF (UNII: ZY81Z83H0X) COCONUT (UNII: 3RT3536DHY) Glycerin (UNII: PDC6A3C0OX) Mineral Oil (UNII: T5L8T28FGP) Tocopherol (UNII: R0ZB2556P8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55910-777-05 177 mL in 1 CAN; Type 0: Not a Combination Product 12/15/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 12/15/2015 Labeler - Dollar General (068331990) Registrant - Product Quest Mfg (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg 927768135 manufacture(55910-777) , label(55910-777)