Label: NATURAL FINISH PRESSED FOUNDATION SPF 20 SUNSCREEN- titanium dioxide and zinc oxide powder
- NDC Code(s): 68078-013-14
- 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.
Drug Label Information
Updated October 5, 2021
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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Uses
- 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.
- Warnings
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Directions
- Apply liberally 15 minutes before sun exposure. Works best on moisturized skin.
- Reapply:
- After 80 minutes of swimming or sweating.
- Immediately after towel drying.
- At least every 2 hours.
- Children under 6 months: ask a doctor.
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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.
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Inactive ingredients
Mica, Ethylhexyl Hydroxystearate Benzoate, Tocopheryl Acetate, Daucus Carota Sativa (Carrot) Seed Oil, Glycerin, Methicone, Dimethicone, Triethoxycaprylylsilane, Lycopodium Clavatum Extract, Imperata Cylindrica Root Extract, Lauroyl Lysine, Silica, Pelargonium Graveolens Flower Oil, Cananga Odorata Flower Oil, Fusanus Spicatus Wood Oil, Phenethyl Alcohol, Sodium Dehydroacetate, Caprylyl Glycol, Phenoxyethanol, Potassium Sorbate, Benzyl Benzoate, Farnesol, Linalool, Bismuth Oxychloride (CI 77163), Chromium Oxide Greens (CI 77288), Iron Oxides (CI 77491, CI 77492, CI 77499)
- Other information
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 12 g Container Carton
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INGREDIENTS AND APPEARANCE
NATURAL FINISH PRESSED FOUNDATION SPF 20 SUNSCREEN
titanium dioxide and zinc oxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68078-013 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 212 mg in 1 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 120 mg in 1 g Inactive Ingredients Ingredient Name Strength Mica (UNII: V8A1AW0880) BENZYL BENZOATE (UNII: N863NB338G) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Carrot Seed Oil (UNII: 595AO13F11) Glycerin (UNII: PDC6A3C0OX) Methicone (20 Cst) (UNII: 6777U11MKT) Dimethicone (UNII: 92RU3N3Y1O) Triethoxycaprylylsilane (UNII: LDC331P08E) LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) Imperata Cylindrica Root (UNII: VYT2JA85NH) Lauroyl Lysine (UNII: 113171Q70B) Silicon Dioxide (UNII: ETJ7Z6XBU4) Pelargonium Graveolens Flower Oil (UNII: 3K0J1S7QGC) YLANG-YLANG OIL (UNII: 8YOY78GNNX) Santalum Spicatum Oil (UNII: H9LVS6REV4) Phenylethyl Alcohol (UNII: ML9LGA7468) Sodium Dehydroacetate (UNII: 8W46YN971G) Caprylyl Glycol (UNII: 00YIU5438U) Phenoxyethanol (UNII: HIE492ZZ3T) Potassium Sorbate (UNII: 1VPU26JZZ4) Bismuth Oxychloride (UNII: 4ZR792I587) Chromic Oxide (UNII: X5Z09SU859) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68078-013-14 1 in 1 CARTON 09/01/2016 1 12 g in 1 CONTAINER; 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 09/01/2016 Labeler - Colorescience (128731929)
