Label: BRIGHTENING PERFECTOR SPF 20 SUNSCREEN- titanium dioxide and zinc oxide liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 68078-015-16 - Packager: Colorescience
- Category: HUMAN OTC DRUG LABEL
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 November 6, 2018
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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 40 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
Cyclopentasiloxane, Dimethicone Crosspolymer, Ethylhexyl Hydroxystearate Benzoate, Glycerin, Dimethicone/Vinyl Dimethicone Crosspolymer, Water, Dimethiconol, Tocopheryl Acetate, Simmondsia Chinensis (Jojoba) Seed Oil, Dimethicone, Stearic Acid, Citrus Paradisi (Grapefruit) Seed Extract, Cyclohexasiloxane, Spirulina Maxima Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Lavandula Angustifolia (Lavender) Oil, Citrus Reticulata (Tangerine) Peel Oil, Avena Sativa (Oat) Kernel Protein, Melissa Officinalis Leaf Powder, Aloe Barbadensis Leaf Extract, Glycine Soja (Soybean) Oil, Palmeria Palmata Extract, Camellia Sinensis Leaf Extract, Beta-Glucan, Avena Sativa (Oat) Kernel Extract, Triethoxycaprylylsilane, Ascorbic Acid, Aluminum Hydroxide, Phenoxyethanol, Limonene, Linalool, Beta Carotene (CI 40800)
- Other information
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton
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INGREDIENTS AND APPEARANCE
BRIGHTENING PERFECTOR SPF 20 SUNSCREEN
titanium dioxide and zinc oxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68078-015 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 25 mg in 1 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 39 mg in 1 mL Inactive Ingredients Ingredient Name Strength Cyclomethicone 5 (UNII: 0THT5PCI0R) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) Ethylhexyl Hydroxystearate Benzoate (UNII: 3W8F25684B) Glycerin (UNII: PDC6A3C0OX) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) Water (UNII: 059QF0KO0R) DIMETHICONOL (100000 CST) (UNII: OSA9UP217S) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) JOJOBA OIL (UNII: 724GKU717M) Dimethicone (UNII: 92RU3N3Y1O) Stearic Acid (UNII: 4ELV7Z65AP) CITRUS PARADISI SEED (UNII: 12F08874Y7) Cyclomethicone 6 (UNII: XHK3U310BA) ARTHROSPIRA MAXIMA (UNII: 9K7IG15M0Q) TEA TREE OIL (UNII: VIF565UC2G) LAVENDER OIL (UNII: ZBP1YXW0H8) CITRUS RETICULATA LEAF OIL (UNII: 1515UE78IH) OAT (UNII: Z6J799EAJK) MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219) ALOE VERA LEAF (UNII: ZY81Z83H0X) SOYBEAN OIL (UNII: 241ATL177A) DULSE (UNII: 7832HOY4ZQ) GREEN TEA LEAF (UNII: W2ZU1RY8B0) POLYSACCHARIDE-K (UNII: 3X48A86C8K) Triethoxycaprylylsilane (UNII: LDC331P08E) Ascorbic Acid (UNII: PQ6CK8PD0R) Aluminum Hydroxide (UNII: 5QB0T2IUN0) Phenoxyethanol (UNII: HIE492ZZ3T) Limonene, (+)- (UNII: GFD7C86Q1W) .BETA.-CAROTENE (UNII: 01YAE03M7J) LINALOOL, (+/-)- (UNII: D81QY6I88E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68078-015-16 1 in 1 CARTON 02/01/2017 1 30 mL in 1 TUBE; 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 02/01/2017 Labeler - Colorescience (128731929)