Label: STILA COLOR CORRECTING BROAD SPECTRUM SPF 20 (ALL SHADES)- octinoxate, titanium dioxide, and zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 76049-906-01 - Packager: Stila Styles, LLC
- 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 November 22, 2013
If you are a consumer or patient please visit this version.
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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
- use a water resistant sunscreen if swimming or sweating
- reapply 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
ACRYLATES CROSSPOLYMER, ACRYLATES/AMMONIUM METHACRYLATE COPOLYMER, ALUMINUM HYDROXIDE, BENZIMIDAZOLE DIAMOND AMIDOETHYL UREA CARBAMOYL PROPYL POLYMETHYLSILSESQUIOXANE, BORON NITRIDE, BUTYLENE GLYCOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, CAPRYLYL GLYCOL, DEXTRIN PALMITATE, DIMETHICONE, DIMETHYLMETHOXY CHROMANYL PALMITATE, DISODIUM EDTA, DISTEARDIMONIUM HECTORITE, ETHANOL, GLYCERIN, GLYCERYL POLYACRYLATE, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, HEXYLENE GLYCOL, LECITHIN, LYSINE, MAGNESIUM ASCORBYL PHOSPHATE, MAGNESIUM CHLORIDE, METHICONE, NYLON-12, PALMITIC ACID, PEG/PPG-18/18 DIMETHICONE, PHENOXYETHANOL, POLYMETHYLSILSESQUIOXANE, POTASSIUM CHLORIDE, ROSE EXTRACT/ROSA CANINA EXTRACT, SACCHARIDE ISOMERATE, SODIUM CHLORIDE, SODIUM DEHYDROACETATE, SODIUM HYALURONATE, SQUALANE, STEARIC ACID, TRIETHOXYCAPRYLYLSILANE, TRIETHYL CITRATE, TRIMETHYLSILOXYSILICATE, WATER (AQUA), XANTHAN GUM, ZINC CHLORIDE, MAY CONTAIN (+/-): CHROMIUM OXIDE GREENS (CI 77288), IRON OXIDES (CI 77491, CI 77492, CI 77499), MICA, TITANIUM DIOXIDE (CI 77891) <ILN C131004>.
- OTHER INFORMATION
- QUESTIONS OR COMMENTS?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 40 ml Tube Carton
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INGREDIENTS AND APPEARANCE
STILA COLOR CORRECTING BROAD SPECTRUM SPF 20 (ALL SHADES)
octinoxate, titanium dioxide, and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76049-906 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 50 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) BORON NITRIDE (UNII: 2U4T60A6YD) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CAPRYLYL GLYCOL (UNII: 00YIU5438U) DIMETHICONE (UNII: 92RU3N3Y1O) DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U) EDETATE DISODIUM (UNII: 7FLD91C86K) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ALCOHOL (UNII: 3K9958V90M) GLYCERIN (UNII: PDC6A3C0OX) HEXYLENE GLYCOL (UNII: KEH0A3F75J) LYSINE (UNII: K3Z4F929H6) MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) NYLON-12 (UNII: 446U8J075B) PALMITIC ACID (UNII: 2V16EO95H1) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) PHENOXYETHANOL (UNII: HIE492ZZ3T) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SACCHARIDE ISOMERATE (UNII: W8K377W98I) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SQUALANE (UNII: GW89575KF9) STEARIC ACID (UNII: 4ELV7Z65AP) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) ZINC CHLORIDE (UNII: 86Q357L16B) CHROMIC OXIDE (UNII: X5Z09SU859) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76049-906-01 1 in 1 CARTON 1 40 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 08/30/2013 Labeler - Stila Styles, LLC (809192896) Establishment Name Address ID/FEI Business Operations GORDON LABORATORIES, INC. 008328619 MANUFACTURE(76049-906)
