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

Stila Color Correcting Broad Spectrum SPF 20 by

Drug Labeling and Warnings

Stila Color Correcting Broad Spectrum SPF 20 by is a Otc medication manufactured, distributed, or labeled by Stila Styles, LLC, GORDON LABORATORIES, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

ACTIVE INGREDIENT

ACTIVE INGREDIENTS		PURPOSE
OCTINOXATE	7.50%	sunscreen
TITANIUM DIOXIDE	5.00%	sunscreen
ZINC OXIDE	1.00%	sunscreen

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

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

• 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
• 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

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

• protect this product from excessive heat and direct sun

QUESTIONS OR COMMENTS?

stilacosmetics.com

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

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

Product 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)