Label: AUSTRALIAN GOLD HELLO KITTY MINERAL FACES SUNSCREEN- titanium dioxide, zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 58443-0219-3 - Packager: Prime Enterprises Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 January 17, 2020
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- Active Ingredients
- Purpose
- Uses
- WARNINGS
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Directions
- apply liberally 15 minutes before sun exposure
- reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
- Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with 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
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INACTIVE INGREDIENT
Acrylates/C12-22 Alkyl Methacrylate Copolymer, Aluminum Hydroxide, Artemisia Princeps (Yomogi) Extract, Buddleja Davidii (Butterfly Bush) Extract, C12-15 Alkyl Benzoate, Ceteareth-20, Cetyl Alcohol, Dibutly Adipate, Dimethicone, Glycerin, Hexyl Laurate, Magnesium Aluminum Silicate, Methylcellulose, Methylisothiazolinone, PEG-12 Dimethicone, Phenoxyethanol, Polyglyceryl-3 Distearate, Propylene Glycol, Stearic Acid, Stearyl Alcohol, Triethoxycaprylylsilane, Trimethylsiloxysilicate, Water (Aqua), Xanthan Gum, may contain Citric Acid, may contain Sodium Hydroxide
- Other Information
- Questions or Comments?
- Australian Gold Hello Kitty Mineral Faces Sunscreen
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INGREDIENTS AND APPEARANCE
AUSTRALIAN GOLD HELLO KITTY MINERAL FACES SUNSCREEN
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0219 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 41.6 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 46.8 mg in 1 mL Inactive Ingredients Ingredient Name Strength POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV) XANTHAN GUM (UNII: TTV12P4NEE) BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CETEARETH-22 (UNII: 28VZG1E234) CETYL ALCOHOL (UNII: 936JST6JCN) PHENOXYETHANOL (UNII: HIE492ZZ3T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DIMETHICONE (UNII: 92RU3N3Y1O) TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2) GLYCERIN (UNII: PDC6A3C0OX) HEXYL LAURATE (UNII: 4CG9F9W01Q) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) METHYLCELLULOSE (100 CPS) (UNII: 4GFU244C4J) WATER (UNII: 059QF0KO0R) PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) BUDDLEJA DAVIDII LEAF (UNII: X380815D32) ARTEMISIA PRINCEPS LEAF OIL (UNII: F9S1101A2V) SODIUM HYDROXIDE (UNII: 55X04QC32I) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) DIBUTYL ADIPATE (UNII: F4K100DXP3) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0219-3 88 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/23/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 12/23/2013 Labeler - Prime Enterprises Inc. (101946028) Registrant - Prime Enterprises Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises Inc. 101946028 pack(58443-0219) , manufacture(58443-0219) , label(58443-0219) , analysis(58443-0219)