Label: FACE AND BODY SUNSCREEN- octinoxate and titanium dioxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 67510-0081-5 - Packager: Kareway Product, Inc.
- 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 October 4, 2019
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Use
- Warnings
- Directions
- Other information
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Inactive Ingredients
Water, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Stearic acid, Ceyearyl Alcohol, Phenoxyethanol, Acrylates/C10-30 Alkyl acrylate crosspolymer, Chlorphenesin, Triethanolamine, Lavandula Angustifolia (Lavender) Extract, Chamomilla Recutita (Matricaria) Flower/Leaf Extract, Borago officinalis Extract, Centaurea cyanus flower Extract, Dimethicone, Butylene Glycol, 1,2-Hexanediol, Ethylhexylglycerin, Disodium EDTA, Fragrance
- Package label
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INGREDIENTS AND APPEARANCE
FACE AND BODY SUNSCREEN
octinoxate and titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67510-0081 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7 g in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.8 g in 100 mL Inactive Ingredients Ingredient Name Strength ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) CETYL ALCOHOL (UNII: 936JST6JCN) DIMETHICONE (UNII: 92RU3N3Y1O) PHENOXYETHANOL (UNII: HIE492ZZ3T) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) PEG-100 STEARATE (UNII: YD01N1999R) (C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8) CHLORPHENESIN (UNII: I670DAL4SZ) TROLAMINE (UNII: 9O3K93S3TK) STEARIC ACID (UNII: 4ELV7Z65AP) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) WATER (UNII: 059QF0KO0R) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67510-0081-5 100 mL in 1 TUBE; Type 0: Not a Combination Product 01/24/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/24/2013 Labeler - Kareway Product, Inc. (121840057)