CC CREAM COMPLEXION CORRECTOR MEDIUM DARK BROAD SPECTRUM SPF 15 JAFRA- avobenzone, octinoxate, octisalate, octocrylene cream

CC Cream Complexion Corrector Medium Dark Broad Spectrum SPF 15 by

Drug Labeling and Warnings

CC Cream Complexion Corrector Medium Dark Broad Spectrum SPF 15 by is a Otc medication manufactured, distributed, or labeled by Jafra cosmetics International, Jafra Cosmetics International, Jafra Manufacturing, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients       Purpose

Avobenzone 2%         Sunscreen

Octinoxate 5%           Sunscreen

Octisalate 4%            Sunscreen

Octocrylene 1.8%       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

Keep out of reach of children

Stop use and ask a doctor if rash occurs

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.

If product is 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

Sun Protection Measures

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk of 15 or higher and other sun protection measures including:

           - limit time in the sun, especially from 10 a.m. - 2p.m.

           - wear long sleeve-shirts, pants, hats, and sunglasses

Water/Aqua, Phenyl Trimethicone, Cyclomethicone, Hydroxypropylcocoate PEG-8 Dimethicone, Triethoxycaprylylsilane, Cyclopentasiloxane, Dimethicone/Vinyl Dimethicone Crosspolymer, Phenyl Dimethicone, Squalane, Trihydroxystearin, Magnesium Aluminum Silicate, Silica, aluminum Starch Octenylsuccinate, Lauryl Lysine, Polysorbate 20, Lecithin, Polymethyl Methacrylate, Caprylyl Glycol, Ethylhexylglycerin, Undecylenoyl Glycine, Hexylene Glycol, Methylisothiazolinone, Xanthan Gum, Sodium Chloride, Cucumis Sativus Extract , Glycyrrhiza Glabra Extract  [May contain/+/-:  Iron Oxides/CI 77491/CI 77492/77499, Titanium Dioxide/CI 77891]

PRINCIPAL DISPLAY PANEL

Jafra CC Creme Complexion Corrector

Complexion Corrector Broad Spectrum SPF 15

30 ml 1 Fl Oz (US)

INGREDIENTS AND APPEARANCE

CC CREAM COMPLEXION CORRECTOR MEDIUM DARK BROAD SPECTRUM SPF 15  JAFRA
avobenzone, octinoxate, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-192
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1.8 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
CYCLOMETHICONE (UNII: NMQ347994Z)
HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE (UNII: 8TE0BZU36S)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SQUALANE (UNII: GW89575KF9)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
LAUROYL LYSINE (UNII: 113171Q70B)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
UNDECYLENOYL GLYCINE (UNII: 4D20464K2J)
CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CUCUMBER (UNII: YY7C30VXJT)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-192-02	1 in 1 CARTON	03/03/2014
1	NDC: 68828-192-01	30 mL in 1 TUBE; 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	03/03/2014

Labeler - Jafra cosmetics International (041676479)

Registrant - Jafra Cosmetics International (041676479)

Establishment
Name	Address	ID/FEI	Business Operations
Jafra Manufacturing, S.A. de C.V.		814732061	manufacture(68828-192)