Label: DARK CC CREME BROAD SPECTRUM SPF 15 JAFRA- zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 68828-237-01, 68828-237-02 - 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 June 17, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- 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 of 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, regularyl use a sunscreen with a Broad Spectrum SPF 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
Water/Aqua, Cyclopentasiloxane, PEG/PPG-18/18 Dimethicone, Cyclomethicone, Caprylic Capric Triglyceride, Polyhyroxystearic Acid, Propanediol, Titanium Dioxide/CI 77891, Triethoxycaprylysilane, Dimethicone, PEG-10 Dimethicone, Disteardimonium Hectorite, Boron Nitride, Iron Oxides/ CI 77491/CI 77492/CI 77499, Methicone, Glycerin, Sodium Chloride, Sodium Dehydroacetate, DMDM Hydantoin, Palmitic Acid, Disodium EDTA, Dextrin, Palmitate, PEG-4 Laurate, Iodopropynyl Butylcarbamate, Cucumis Sativus Extract, Glycrrhiza Glabra Extract, Tocopherol
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DARK CC CREME BROAD SPECTRUM SPF 15 JAFRA
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-237 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 6.8 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) CYCLOMETHICONE (UNII: NMQ347994Z) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) PROPANEDIOL (UNII: 5965N8W85T) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) DIMETHICONE (UNII: 92RU3N3Y1O) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) BORON NITRIDE (UNII: 2U4T60A6YD) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) METHICONE (20 CST) (UNII: 6777U11MKT) GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) DMDM HYDANTOIN (UNII: BYR0546TOW) PALMITIC ACID (UNII: 2V16EO95H1) EDETATE DISODIUM (UNII: 7FLD91C86K) PEG-4 LAURATE (UNII: AYF4VM3N1Z) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) CUCUMBER (UNII: YY7C30VXJT) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) TOCOPHEROL (UNII: R0ZB2556P8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-237-02 1 in 1 BOX 07/13/2015 1 NDC:68828-237-01 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 07/13/2015 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(68828-237)
