CC CUSHION COMPACT SUNSCREEN - MEDIUM / DEEP- titanium dioxide, zinc oxide cream 
Skin Pi 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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CC Cushion Compact SunScreen - Medium / Deep

DRUG FACTS

Active Ingredients: each 15 g contains

Titanium Dioxide - 22.4%

Zinc Oxide - 0.5%

PURPOSE

Sunscreen

USES: Help to prevent sunburn. If used as directed with other sun protection measures (see directions) may decrease the risk of skin cancer and early skin ageing caused by the sun.

Warnings- For external use only. Do not use on damaged or broken skin.
When using this product: Keep out of the eyes. Rinse with water to remove.
Stop use and ask a doctor If rash occurs.

Keep out the of reach of children. If product is swallowed, get medical help or contact a poison control center right away.

Directions: Apply liberally 15 minutes before sun exposure.

Reapply

Inactive Ingredients: Water(Aqua), Shea Butter, Jojoba Oil, Cucumber Extract, Grape Seed Oil, Yellow Beeswax, Chamomile Extract, Iron Oxide CI : 77492, Glycerin(and)Water(and) Dextran(and)Caprooyl Tetrapeptide-3, Mandelic Acid, Ascorbyl Glucoside, Aqua /Water (and) Tripleurospermum Maritimum Extract, Iron Oxide CI : 77491, Hyaluronic Acid, Iron Oxide CI : 77499, Phenoxyethanol, Vitamin-E.

Color Control

SunScreen Broad spectrum SPF50+

Covers . Brightens . Protects . Soothes . Hydrates

Packaging

image description

CC CUSHION COMPACT SUNSCREEN - MEDIUM / DEEP 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71190-9387
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE22.4 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SHEA BUTTER (UNII: K49155WL9Y)  
JOJOBA OIL (UNII: 724GKU717M)  
CUCUMBER (UNII: YY7C30VXJT)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CHAMOMILE (UNII: FGL3685T2X)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
GLYCERIN (UNII: PDC6A3C0OX)  
DEXTRAN 40 (UNII: K3R6ZDH4DU)  
CAPROOYL TETRAPEPTIDE-3 (UNII: LZI0HJ3K2R)  
MANDELIC ACID (UNII: NH496X0UJX)  
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
TRIPLEUROSPERMUM INODORUM WHOLE (UNII: 567N54UG4S)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
HYALURONIC ACID (UNII: S270N0TRQY)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71190-9387-41 in 1 CARTON01/18/2017
115 g in 1 BOX; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/18/2017
Labeler - Skin Pi LLC (080439471)

Revised: 1/2017
Document Id: da63084a-81f7-421e-a45f-61a59a586f4b
Set id: d96f9470-67d4-41da-9c5c-3ec3fbd9582e
Version: 1
Effective Time: 20170120
 
Skin Pi LLC