CLEAN TINTED- zinc oxide lotion

Clean Tinted by

Drug Labeling and Warnings

Clean Tinted by is a Otc medication manufactured, distributed, or labeled by Clean, Know What's On Your Skin LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Zinc Oxide 12%

Purpose:

Sunscreen

Uses

helps prevent sunburn
If used as directed with other sun protection measures (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Do not use

on damaged or broken skin

When using this product:

keep out of the eyes. Rinse with water to remove. 

Stop use and ask doctor

is skin rash occurs

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

apply liberally 15 minutes before sun exposure
reapply:
 after 80 minutes of swimming or sweating
 Immediately after towel drying
 at least every two hours
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the 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

Inactive Ingredients

Alcohol, Aloe Barbadensis Leaf Juice Powder, Ascorbyl Palmitate, Bisabolol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, C16 Alpha Olefin, Capryl Glycol, Caprylyl Methicone, Cetyl PEG/PPG-10/1 Dimethicone, Chamomilla Recutita (Matricaria) Flower Extract*, Citrus Aurantium Dulcis (Orange) Fruit Extract*, Citrus Aurantium Dulcis (Orange) Peel Extract*, Dimethiconol/Propylsilsesquioxane/Silicate Crosspolymer, Ethylhexylglycerin, Fucus Vesiculosus Extract, Simmondsia Chinensis (Jojoba) Seed Oil*, Glycerin*,Hexylene Glycol, Iron Oxides, Isododecane, Oenothera Biennis (Evening Primrose) Oil*, Palmaria Palmata Extract, Phenoxyethanol, Propanediol, Rosa Canina Fruit Oil*, Sodium Chloride, Tetrasodium Glutamate Diacetate, Tocopherol, Triethoxycaprylylsilane, Trilaureth-4 Phosphate, VP/ Eicosene Copolymer, Water, Zostera Marina Extract *=Organic

Other information

protect this product from excessive heat and direct sun

Questions or comments?

Call 424-272-6522

Clean Tinted Lotion, 50mL (72394-000-00)

INGREDIENTS AND APPEARANCE

CLEAN TINTED 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72394-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	120 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
LEVOMENOL (UNII: 24WE03BX2T)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
CHAMOMILE (UNII: FGL3685T2X)
ORANGE (UNII: 5EVU04N5QU)
ORANGE PEEL (UNII: TI9T76XD44)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ISODODECANE (UNII: A8289P68Y2)
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)
DULSE (UNII: 7832HOY4ZQ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPANEDIOL (UNII: 5965N8W85T)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
TOCOPHEROL (UNII: R0ZB2556P8)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72394-001-00	50 mL in 1 TUBE; Type 0: Not a Combination Product	07/18/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/18/2018

Labeler - Clean, Know What's On Your Skin LLC (081544845)