STILA CC COLOR CORRECTING BROAD-SPECTRUM SPF 20 (ALL SHADES)- octocrylene, octisalate, avobenzone, and octinoxate stick

Stila CC Color Correcting Broad-Spectrum SPF 20 by

Drug Labeling and Warnings

Stila CC Color Correcting Broad-Spectrum SPF 20 by is a Otc medication manufactured, distributed, or labeled by Stila Styles, LLC, Bkolor Makeup & Skincare S.R.L.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

ACTIVE INGREDIENT

ACTIVE INGREDIENTS		PURPOSE
Octocrylene	4.00%	sunscreen
Octisalate	4.00%	sunscreen
Avobenzone	1.50%	sunscreen
Octinoxate	6.50%	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

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

• 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 - 15 g Applicator Carton

stila

cc
color correcting stick
broad-spectrum SPF 20

NET WT. 0.52 OZ./15 g

INGREDIENTS AND APPEARANCE

STILA CC COLOR CORRECTING BROAD-SPECTRUM SPF 20   (ALL SHADES)
octocrylene, octisalate, avobenzone, and octinoxate stick

Product 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)