Label: FACE AND BODY SUNSCREEN- octinoxate and titanium dioxide lotion
- 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.
Updated February 27, 2013
If you are a consumer or patient please visit this version.
- Active Ingredients
Octyl Methoxycinnamate 7%
Titanium Dioxide 2.8%Close
helps prevent sunburnClose
Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.
For external use only
Keep out of reach of children.
If product is swallowed, get medical help or call a Poison Control Center right away.
- apply liberally 15 minutes before sun exposure
- after 40 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
- children under 6 months: Ask a doctor
- Other information
- protect this product from excessive heat and direct sun
- may stain fabrics
- for Lot and Expiration Date, see crimp of tube
- Inactive Ingredients
beeswax, carbomer, cetyl alcohol, dimethicone, disodium edta, fragrance, glycerin, glyceryl stearate se, glyceryl stearate and peg-100 stearate, methylparaben, propylene glycol, propylparaben, stearic acid, triethanolamine, waterClose
- Package label
Face and Body SunscreenClose
- INGREDIENTS AND APPEARANCE
FACE AND BODY SUNSCREEN
octinoxate and titanium dioxide lotion
Product 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 YELLOW WAX (UNII: 2ZA36H0S2V) CETYL ALCOHOL (UNII: 936JST6JCN) DIMETHICONE (UNII: 92RU3N3Y1O) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) STEARIC ACID (UNII: 4ELV7Z65AP) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67510-0081-5 100 mL in 1 TUBE 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)