COVERQUEEN ALL IN ONE SUN ROLL- zinc oxide, titanium dioxide, niacinamide, adenosine cream

COVERQUEEN All in one sun roll by

Drug Labeling and Warnings

COVERQUEEN All in one sun roll by is a Otc medication manufactured, distributed, or labeled by SKINFARM. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Zinc Oxide, Titanium Dioxide, Niacinamide, Adenosine

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

Helps prevent sunburn*if used as directed with other sun protection measures (see under Directions), decreases the risk of skin cancer and early skin aging by the sun

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF THE CHILDREN

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

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

external use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COVERQUEEN ALL IN ONE SUN ROLL 
zinc oxide, titanium dioxide, niacinamide, adenosine cream

Product 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)