Label: CLEAN- zinc oxide lotion
-
Contains inactivated NDC Code(s)
NDC Code(s): 72394-000-00 - Packager: Clean, Know What's On Your Skin LLC
- 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 29, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients
- Uses
- Warnings
-
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, Isododecane, Oenothera Biennis (Evening Primrose) Oil*, Palmaria Palmata Extract, Phenoxyethanol, Propanediol, Rosa Canina Fruit Oil*, Sodium Chloride, Tetrasodium Glutamate Diacetate, Tocopherol, Trilaureth-4 Phosphate, VP/ Eicosene Copolymer, Water, Zostera Marina Extract *=Organic
- Other information
- Questions or comments?
- Clean Lotion, 100mL (72394-000-01)
-
INGREDIENTS AND APPEARANCE
CLEAN
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72394-000 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) 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) TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72394-000-00 100 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)
