Label: LONG WEAR MAKEUP BROAD SPECTRUM SPF 20 NUDE JAFRA- octisalate, zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 68828-263-01, 68828-263-02 - 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 23, 2020
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 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 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, Caprylic Capric Triglyceride, Polyhydroxystearic Acid, Cyclomethicone, Hydroxypropylcocoate PEG-8 Dimethicone, Phenyl Triemthicone, C12-15 Alkyl Benzoate, Dimethicone, Dimethicone Crosspolymer, Caprylic/Capric Triglyceride, Phenyl Dimethicone, Di-PPG-3 Myristyl Ether Adipate, Caprylyl Methicone, PEG-10 Dimethicone, Disteardimonium Hectorite, Propanediol, Sodium Chloride, Squalane,Boron Nitride, Synthetic Fluorophlogopite, Aloe Barbadensis Leaf Juice, DMDM Hydantoin, Dextrin Palmitate, Oryza Sativa (Rice) Bran Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Helianthus Anuus (Sunflower) Extract, Tocopherol, Tocopheryl Acetate, PEG-4 Laurate, Iodopropynyl Butylcarbamate, Sodium Hyaluronate, Butylene Glycol, Glycyrrhiza Glabra (Licorice) Extract, Benzimidazole Diamond Amidoethyl Urea Carbamoyl Propyl Polymehtylsilsesquioxane, Lentinus Edodes (shiitake) Extract, Ipomoea Batatas Tuber Extract, Centella Asiatica Extract, Withania Somniferia Extract, Butylene Glycol, Biosaccharide Gum-4, Smithsonite Extact, Chondrus Crispus (Carrageenan) Extract, Triethoxycaprylylsilane [May Containt +/-: Titanium Dioxide, Iron Oxides/ CI 77492/ CI 77491/ CI 77499]
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LONG WEAR MAKEUP BROAD SPECTRUM SPF 20 NUDE JAFRA
octisalate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-263 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 3 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 6.8 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) CYCLOMETHICONE (UNII: NMQ347994Z) HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE (UNII: 8TE0BZU36S) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) DIMETHICONE (UNII: 92RU3N3Y1O) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) DI-PPG-3 MYRISTYL ETHER ADIPATE (UNII: T32481VTXW) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) PROPANEDIOL (UNII: 5965N8W85T) SODIUM CHLORIDE (UNII: 451W47IQ8X) SQUALANE (UNII: GW89575KF9) BORON NITRIDE (UNII: 2U4T60A6YD) ALOE VERA LEAF (UNII: ZY81Z83H0X) DMDM HYDANTOIN (UNII: BYR0546TOW) DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3) RICE BRAN (UNII: R60QEP13IC) ROSEMARY (UNII: IJ67X351P9) HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP) TOCOPHEROL (UNII: R0ZB2556P8) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PEG-4 LAURATE (UNII: AYF4VM3N1Z) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) HYALURONATE SODIUM (UNII: YSE9PPT4TH) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) LICORICE (UNII: 61ZBX54883) LENTINULA EDODES MYCELIUM (UNII: CU2S39TB8O) SWEET POTATO (UNII: M9WGG9Z9GK) CENTELLA ASIATICA (UNII: 7M867G6T1U) WITHANIA SOMNIFERA LEAF (UNII: J337CNM3CW) BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90) CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) Other Ingredients Ingredient Kind Ingredient Name Quantity May contain TITANIUM DIOXIDE (UNII: 15FIX9V2JP) May contain FERRIC OXIDE YELLOW (UNII: EX438O2MRT) May contain FERRIC OXIDE RED (UNII: 1K09F3G675) May contain FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-263-02 1 in 1 BOX 02/21/2017 1 NDC:68828-263-01 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 02/21/2017 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(68828-263)