Label: CC CREAM COMPLEXION CORRECTOR MEDIUM DARK BROAD SPECTRUM SPF 15 JAFRA- avobenzone, octinoxate, octisalate, octocrylene cream
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Contains inactivated NDC Code(s)
NDC Code(s): 68828-192-01, 68828-192-02 - Packager: Jafra cosmetics International
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 January 28, 2019
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- Official Label (Printer Friendly)
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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]
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INGREDIENTS AND APPEARANCE
CC CREAM COMPLEXION CORRECTOR MEDIUM DARK BROAD SPECTRUM SPF 15 JAFRA
avobenzone, octinoxate, octisalate, octocrylene creamProduct 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)