Label: FACE AND BODY SUNSCREEN- octinoxate and titanium dioxide lotion
- NDC Code(s): 59970-074-01
- Packager: Navarro Discount Pharmacies,LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- 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
Vida Mia Sunscreen LotionClose
- INGREDIENTS AND APPEARANCE
FACE AND BODY SUNSCREEN
octinoxate and titanium dioxide lotion
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59970-074 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (OCTINOXATE) OCTINOXATE 7 mg in 100 mg TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 2.8 mg in 100 mg Inactive Ingredients Ingredient Name Strength YELLOW WAX CETYL ALCOHOL DIMETHICONE EDETATE DISODIUM GLYCERIN GLYCERYL MONOSTEARATE PEG-100 STEARATE METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN STEARIC ACID TROLAMINE WATER Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59970-074-01 113400 mg 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 - Navarro Discount Pharmacies,LLC (094930963)