Label: STILA CC COLOR CORRECTING BROAD-SPECTRUM SPF 20 (ALL SHADES)- octocrylene, octisalate, avobenzone, and octinoxate stick
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Contains inactivated NDC Code(s)
NDC Code(s): 76049-899-01 - Packager: Stila Styles, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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.
- Download DRUG LABEL INFO: PDF XML
- 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
ALUMINUM HYDROXIDE, ALUMINUM STARCH OCTENYLSUCCINATE, ASCORBYL TETRAISOPALMITATE, C12-15 ALKYL BENZOATE, CAMELLIA SINENSIS LEAF EXTRACT, CAPRYLYC/CAPRIC TRIGLYCERIDE, CERAMIDE 2, COPERNICIA CERIFERA (CARNAUBA) WAX/COPERNICIA CERIFERA CERA, DIMETHICONE, ETHYLHEXYL PALMITATE, EUPHORBIA CERIFERA (CANDELILLA) WAX/CANDELILLA CERA, FRAGRANCE/PARFUM, GLYCYRRHIZA GLABRA EXTRACT/ GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, HELIANTHUS ANNUUS SEED OIL/HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, ISONONYL ISONONANOATE, KAOLIN, MICROCRYSTALLINE WAX/MICROCRISTALLINA CERA, ORYZANOL, PALMITOYL OLIGOPEPTIDE, PEG-10 RAPESEED STEROL, POLYETHYLENE, POLYMETHYL METHACRYLATE, PTFE, SILICA, SORBITAN SESQUIISOSTEARATE, SORBITAN SESQUIOLEATE, STEARIC ACID, SYNTHETIC WAX, TALC, TOCOPHERYL ACETATE, TRIBEHENIN, TRIMETHYLSILOXYPHENYL DIMETHICONE, MAY CONTAIN (+/-): CHROMIUM HYDROXIDE GREEN (CI 77289), IRON OXIDES (CI 77491, CI 77492, CI 77499), RED 7 LAKE (CI 15850), TITANIUM DIOXIDE (CI 77891), ULTRAMARINES (CI 77007) <ILN C131002>.
- OTHER INFORMATION
- QUESTIONS OR COMMENTS?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 15 g Applicator Carton
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INGREDIENTS AND APPEARANCE
STILA CC COLOR CORRECTING BROAD-SPECTRUM SPF 20 (ALL SHADES)
octocrylene, octisalate, avobenzone, and octinoxate stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76049-899 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 40 mg in 1 g Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 40 mg in 1 g Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 15 mg in 1 g Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 65 mg in 1 g Inactive Ingredients Ingredient Name Strength ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) GREEN TEA LEAF (UNII: W2ZU1RY8B0) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CERAMIDE 2 (UNII: C04977SRJ5) CARNAUBA WAX (UNII: R12CBM0EIZ) DIMETHICONE (UNII: 92RU3N3Y1O) ETHYLHEXYL PALMITATE (UNII: 2865993309) CANDELILLA WAX (UNII: WL0328HX19) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) SUNFLOWER OIL (UNII: 3W1JG795YI) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) KAOLIN (UNII: 24H4NWX5CO) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) GAMMA ORYZANOL (UNII: SST9XCL51M) PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C) PEG-10 RAPESEED STEROL (UNII: 258O76T85M) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TRIBEHENIN (UNII: 8OC9U7TQZ0) CHROMIUM HYDROXIDE GREEN (UNII: RV8FT8XF5R) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) D&C RED NO. 7 (UNII: ECW0LZ41X8) ALUMINUM OXIDE (UNII: LMI26O6933) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) ULTRAMARINE BLUE (UNII: I39WR998BI) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76049-899-01 1 in 1 CARTON 1 15 g in 1 APPLICATOR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 08/31/2013 Labeler - Stila Styles, LLC (809192896) Establishment Name Address ID/FEI Business Operations Bkolor Makeup & Skincare S.R.L. 439270534 MANUFACTURE(76049-899)
