Label: COVERQUEEN ALL IN ONE SUN ROLL- zinc oxide, titanium dioxide, niacinamide, adenosine cream
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Contains inactivated NDC Code(s)
NDC Code(s): 73793-0013-1 - Packager: SKINFARM
- 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 March 25, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Water, Propylheptyl Caprylate, Acrylates Copolymer, Butyloctyl Salicylate, Dicaprylyl Ether, Butylene Glycol, Dicaprylate/Dicaprate, Disiloxane, Propanediol, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Silica, Dimethicone, Aluminum Hydroxide, Stearic Acid, Triethoxycaprylylsilane, Cetyl PEG/PPG-10/1 Dimethicone, Ethylhexylglycerin, Disteardimonium Hectorite, Magnesium Sulfate, 1,2-Hexanediol, Disodium EDTA, Fragrance, Citral, Citronellol, Limonene, Hexyl Cinnamal, Hydroxycitronellal, Linalool, Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde,
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
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INDICATIONS & USAGE
Directions
*Apply liberally 15 minutes before sun exposure
*Apply all skin will be exposed to the sun
*Reapply *after 80 minutes of swimming or sweating *immediately after towel drying
*at least every 2 hours
*children under the age of 6 months of age: 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 sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: *limit time in the sun, especially from 10 AM to 2 PM *wear long-sleeve shirts, pants, hats, and sunglasses
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WARNINGS
Warnings
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 redness occurs
Keep out of reach of children if swallowed, get medical help or contact Poison Control Center right away
Other information
*do not store this product under the direct sun light or the excessive heat
*may stain some fabrics or surfaces
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
COVERQUEEN ALL IN ONE SUN ROLL
zinc oxide, titanium dioxide, niacinamide, adenosine creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73793-0013 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ADENOSINE (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567) ADENOSINE 0.04 g in 100 g NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 2 g in 100 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 7 g in 100 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 13 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73793-0013-1 40 g in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/01/2021 Labeler - SKINFARM (688594873) Registrant - SKINFARM (688594873) Establishment Name Address ID/FEI Business Operations SKINFARM 688594873 manufacture(73793-0013)
