Label: KIDS SUNSCREEN- octinoxate and titanium dioxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 67510-0082-5 - 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
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- 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, Cetearyl Alcohol, Phenoxyethanol,
Acrylates/C10-30 alkyl acrylate crosspolymer, Chlorphenesin,
Triethanolamine, Lavandula Angustifolia (Lavender) Extract,
Salvia Sclarea (Clary) Extract, Hyacinthus Orientalis 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
KIDS SUNSCREEN
octinoxate and titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67510-0082 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 GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) STEARIC ACID (UNII: 4ELV7Z65AP) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) CHLORPHENESIN (UNII: I670DAL4SZ) PHENOXYETHANOL (UNII: HIE492ZZ3T) CETYL ALCOHOL (UNII: 936JST6JCN) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67510-0082-5 100 mL in 1 TUBE; Type 0: Not a Combination Product 12/01/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 12/01/2011 Labeler - Kareway Product, Inc. (121840057)