Label: CC CREME CONCEALER BROAD SPECTRUM SPF 20 JAFRA- avobenzone, homosalate, octisalate, octocrylene cream
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Contains inactivated NDC Code(s)
NDC Code(s): 68828-241-01, 68828-241-02 - Packager: Jafra Cosmetics International
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 April 4, 2019
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
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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
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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
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INGREDIENTS AND APPEARANCE
CC CREME CONCEALER BROAD SPECTRUM SPF 20 JAFRA
avobenzone, homosalate, octisalate, octocrylene creamProduct 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)