Label: ONALT PURE MILD SUNCREAM- titanium dioxide, zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 80564-0001-1 - Packager: HnB9 Co., Ltd.
- 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 September 21, 2020
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- WARNINGS
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Water
C12-15 Alkyl Benzoate
Cyclopentasiloxane
Glycerin
Methylpropanediol
Cetyl PEG/PPG-10/1 Dimethicone
Aluminum Hydroxide
Polyhydroxystearic Acid
Niacinamide
Cetyl Dimethicone
Sea Water
Cetyl Ethylhexanoate
Sorbitan Trioleate
Stearic Acid
Isostearic Acid
Sorbitan Sesquioleate
Trifluoropropyl Dimethicone
Benzyl Glycol
Disteardimonium Hectorite
Ozokerite
Sodium Chloride
Butylene Glycol
Silica Dimethyl Silylate
Polymethylsilsesquioxane
Fragrance
Silica
Tocopheryl Acetate
Sargassum Fulvellum Extract
Ethylhexylglycerin
Hizikia Fusiforme Extract
1,2-Hexanediol
Adenosine
Disodium EDTA
Ethylhexylglycerin - INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ONALT PURE MILD SUNCREAM
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80564-0001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 10 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 12 g in 100 mL Inactive Ingredients Ingredient Name Strength ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80564-0001-1 50 mL in 1 TUBE; Type 0: Not a Combination Product 09/22/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 09/22/2020 Labeler - HnB9 Co., Ltd. (694434516) Registrant - HnB9 Co., Ltd. (694434516) Establishment Name Address ID/FEI Business Operations HnB9 Co., Ltd. 694434516 manufacture(80564-0001)