SUPER CC COLOR CORRECTION CARE PRIMER STICK SPF 30- octinoxate, octocrylene, oxybenzone,titanium dioxide, zinc oxide stick

Super CC Color Correction Care Primer Stick by

Drug Labeling and Warnings

Super CC Color Correction Care Primer Stick by is a Otc medication manufactured, distributed, or labeled by Physicians Formula Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Octinoxate 5.6%, Titanium Dioxide 5.2%

Octocrylene 4.2% Zinc Oxide 4.0%

Oxybenzone 5.1%

Purpose

Sunscreen

Use

▪ 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

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:

▪ Immediately after towel drying At least every 2 hours 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 of 15 or higher and other sun protection measures

including: ▪ Limit time in sun, especially from 10 a.m.- 2 p.m.

▪ Wear long-sleeve shirts, pants, hats, and sunglasses ▪ Children under

6 months: Ask a doctor

Inactive Ingredients

Ethylhexyl Palmitate, Silica, Caprylic/Capric, Triglyceride, Triisotridecyl Trimellitate, C12-15 Alkyl Benzoate, Hydrogenated Microcrystalline Wax, HDI/Trimethylol Hexyllactone Crosspolymer, Aluminum Starch Octenylsuccinate, Polyethylene,Ozokerite, Synthetic Wax, Hydroxycapric Acid, Hydroxycaprylic Acid, Hydroxycinnamic Acid, Teprenone, Butylene Glycol, Dimethicone, Hydrogen Dimethicone, Kaolin, Mica, PEG-4, Synthetic Fluorphlogopite, Tin Oxide, Phenxoyethanol. May Contain: Blue 1 Lake, Iron Oxides, Red 40 Lake, Titanium Dioxide, Yellow 5 Lake

Other information

▪ Protect this product from excessive heat and direct sun

Questions or Comments?

▪ Call 1-800-227-0333 (USA only) or www.PhysiciansFormula.com

Package Label

INGREDIENTS AND APPEARANCE

SUPER CC COLOR CORRECTION CARE PRIMER STICK  SPF 30
octinoxate, octocrylene, oxybenzone,titanium dioxide, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 31645-189
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	5.1 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	4 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4.2 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	5.6 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5.2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STANNIC OXIDE (UNII: KM7N50LOS6)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
TRIISODECYL TRIMELLITATE (UNII: 6IFP38QKFS)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
LOW DENSITY POLYETHYLENE (UNII: J245LN42AI)
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)
HYDROXYCAPRIC ACID (UNII: B41993WR8W)
HYDROXYCAPRYLIC ACID (UNII: 0R6X0G0S8A)
P-COUMARIC ACID (UNII: IBS9D1EU3J)
TEPRENONE (UNII: S8S8451A4O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE 20 (UNII: H8YMB5QY0D)
KAOLIN (UNII: 24H4NWX5CO)
MICA (UNII: V8A1AW0880)
POLYETHYLENE GLYCOL 200 (UNII: R95B8J264J)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 31645-189-01	1 in 1 BOX	01/15/2016
1	NDC: 31645-189-47	13.5 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/15/2016

Labeler - Physicians Formula Inc (021261805)