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

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 Creme Concealer Broad Spectrum SPF 20

Active ingredients        Purpose

Avobenzone 3%        Sunscreen

Homosalate 5%         Sunscreen

Octisalate 5%            Sunscreen

Octocrylene 7%         Sunscreen

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.  If product is swallowed, get medical help or contact a Poison Control Center right away

Stop use and ask a doctor if rash occurs

warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes.

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 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]

CC Creme Concealer Broad Spectrum SPF 20

1.8g Net wt. .06 oz

CC creme carton back

CC creme carton front

CC CREME CONCEALER BROAD SPECTRUM SPF 20  JAFRA
avobenzone, homosalate, octisalate, octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-241
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68828-241-021 in 1 CARTON08/11/2015
1NDC:68828-241-011.8 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/11/2015
Labeler - Jafra Cosmetics International (041676479)
Registrant - Jafra Cosmetics International (041676479)
Establishment
NameAddressID/FEIBusiness Operations
Jafra Manufacturing, S.A. de C.V814732061manufacture(68828-241)

Revised: 4/2019
Document Id: d8a32544-92b4-417d-8c90-5740b9a2856b
Set id: 57ffb3f5-2388-44ba-a821-433f94e4ccfa
Version: 3
Effective Time: 20190404
 
Jafra Cosmetics International