Label: SPF 20 LOOSE MINERAL FOUNDATION- titanium dioxide and zinc oxide powder
- NDC Code(s): 68078-000-01
- Packager: Colorescience
- 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 November 5, 2018
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Helps prevent sunburn.
- If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
- Apply liberally 15 minutes before sun exposure. Works best on moisturized skin.
- After 80 minutes of swimming or sweating.
- Immediately after towel drying.
- At least every 2 hours.
- Children under 6 months: ask a doctor.
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 a Broad Spectrum SPF value 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-sleeved shirts, pants, hats, and sunglasses.
- Inactive ingredients
- Other information
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 6 g Tube Carton
INGREDIENTS AND APPEARANCE
SPF 20 LOOSE MINERAL FOUNDATION
titanium dioxide and zinc oxide powder
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68078-000 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 186 mg in 1 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 59 mg in 1 g Inactive Ingredients Ingredient Name Strength Mica (UNII: V8A1AW0880) Bismuth Oxychloride (UNII: 4ZR792I587) Dimethicone (UNII: 92RU3N3Y1O) Methicone (20 CST) (UNII: 6777U11MKT) Triethoxycaprylylsilane (UNII: LDC331P08E) Calcium Silicate (UNII: S4255P4G5M) Chromic Oxide (UNII: X5Z09SU859) Sodium Sulfate (UNII: 0YPR65R21J) Ferric Oxide Red (UNII: 1K09F3G675) Ferrosoferric Oxide (UNII: XM0M87F357) Ferric Oxide Yellow (UNII: EX438O2MRT) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68078-000-01 1 in 1 CARTON 10/01/2015 1 6 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 10/01/2015 Labeler - Colorescience (128731929)