Label: SUPER CC COLOR CORRECTION CARE PRIMER STICK SPF 30- octinoxate, octocrylene, oxybenzone,titanium dioxide, zinc oxide stick
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Contains inactivated NDC Code(s)
NDC Code(s): 31645-189-01, 31645-189-47 - Packager: Physicians Formula Inc
- 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 January 20, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Use
- Warnings
- When using this product
- Keep out of reach of children
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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
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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
- Questions or Comments?
- Package Label
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INGREDIENTS AND APPEARANCE
SUPER CC COLOR CORRECTION CARE PRIMER STICK SPF 30
octinoxate, octocrylene, oxybenzone,titanium dioxide, zinc oxide stickProduct 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)