CC CREME CONCEALER BROAD SPECTRUM SPF 20 JAFRA- avobenzone, homosalate, octisalate, octocrylene cream

CC Creme Concealer Broad Spectrum SPF 20 by

Drug Labeling and Warnings

CC Creme Concealer Broad Spectrum SPF 20 by is a Otc medication manufactured, distributed, or labeled by 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 3%        Sunscreen

Homosalate 5%         Sunscreen

Octisalate 5%            Sunscreen

Octocrylene 7%         Sunscreen

PURPOSE

Uses

helps prevent sunburn

if used as directed with other sun protection measures (see Directions), decreases the risk of cancer and early skin aging

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.  If product is swallowed, get medical help or contact a Poison Control Center right away

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs

WARNINGS

warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes.

DOSAGE & ADMINISTRATION

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 sleeve shirts, pants, hats, and sunglasses

INACTIVE INGREDIENT

Inactive ingredients

Caprylic/Capric Triglyceride, Ethylhexyl Palmitate, Diisopropyl Dimer Dilinoleate, Ozokerite, Euphorbia Cerifera (Candelilla) Wax/Candelilla Cera, Bis-Stearyl Dimethicone, Copernicia Cerifera (Carnauba) Wax, Beeswax- /Cera Alba, Ricinus Communis (Castor) Seed Oil, Stearalkonium Hectorite, Propylene Carbonate, Oryza Sativa (Rice) Bran Extract, Aluminum Starch Octenylsuccinate, Lauroyl Lysine, Rosmarinus Officinalis (Rosemary) Leaf Extract, Helianthus Anuus (Sunflower) Extract, Tocopherol, Silica Silylate, Cucumis Sativus Extract, Glycyrrhiza Glabra Extract, Biosaccharide Gum-4, Chondrus Crispus (Carrageenan) Extract, Water [May Contain +/-: Iron Oxides/CI 77491/CI 77492/CI 77499, Titanium Dioxide/CI 77891]

PRINCIPAL DISPLAY PANEL

CC Creme Concealer Broad Spectrum SPF 20

1.8g Net wt. .06 oz

INGREDIENTS AND APPEARANCE

CC CREME CONCEALER BROAD SPECTRUM SPF 20  JAFRA
avobenzone, homosalate, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-241
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
CERESIN (UNII: Q1LS2UJO3A)
CANDELILLA WAX (UNII: WL0328HX19)
CARNAUBA WAX (UNII: R12CBM0EIZ)
WHITE WAX (UNII: 7G1J5DA97F)
CASTOR OIL (UNII: D5340Y2I9G)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
RICE BRAN (UNII: R60QEP13IC)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
LAUROYL LYSINE (UNII: 113171Q70B)
ROSEMARY (UNII: IJ67X351P9)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
TOCOPHEROL (UNII: R0ZB2556P8)
CUCUMBER (UNII: YY7C30VXJT)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)
CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)
WATER (UNII: 059QF0KO0R)
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: 68828-241-02	1 in 1 CARTON	08/11/2015
1	NDC: 68828-241-01	1.8 g 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 not final	part352	08/11/2015

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(68828-241)