STILA COLOR CORRECTING BROAD SPECTRUM SPF 20  (ALL SHADES)- octinoxate, titanium dioxide, and zinc oxide cream 
Stila Styles, LLC

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.

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Stila Color Correcting Broad Spectrum SPF 20
(All Shades)

DRUG FACTS

ACTIVE INGREDIENTSPURPOSE
OCTINOXATE7.50%sunscreen
TITANIUM DIOXIDE5.00%sunscreen
ZINC OXIDE1.00%sunscreen

USES

WARNINGS

FOR EXTERNAL USE ONLY.

DO NOT USE ON DAMAGED OR BROKEN SKIN.

WHEN USING THIS PRODUCT KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.

STOP USE AND ASK A DOCTOR IF RASH OCCURS.

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

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?

stilacosmetics.com

dist. by © stila styles, llc • los angeles, ca 90027

PRINCIPAL DISPLAY PANEL - 40 ml Tube Carton

stila

CC

color correcting cream
broad-spectrum SPF 20

1.3 FL. OZ./40 ml

Principal Display Panel - 40 ml Tube Carton
STILA COLOR CORRECTING BROAD SPECTRUM SPF 20   (ALL SHADES)
octinoxate, titanium dioxide, and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76049-906
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE50 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76049-906-011 in 1 CARTON
140 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35208/30/2013
Labeler - Stila Styles, LLC (809192896)
Establishment
NameAddressID/FEIBusiness Operations
GORDON LABORATORIES, INC.008328619MANUFACTURE(76049-906)

Revised: 11/2013
Document Id: fd45043a-ca8a-4284-868d-f940b7b19f33
Set id: 24c22cb0-d486-4949-8c00-ef973eac7225
Version: 1
Effective Time: 20131122
 
Stila Styles, LLC