![SABLE LONG WEAR MAKEUP BROAD SPECTRUM SPF 20 (OCTISALATE, ZINC OXIDE) CREAM [JAFRA COSMETICS INTERNATIONAL]](https://medic.hrt.org//dailymed/images/41bffbdc-6fac-4b23-8c02-131bd1dfc558/COLR-117UCLongWearMkupSpf20USA.jpg)
| NDC | 68828-337-01, 68828-337-02 |
| Set ID | 41bffbdc-6fac-4b23-8c02-131bd1dfc558 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | JAFRA COSMETICS INTERNATIONAL |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
-
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
-
INACTIVE INGREDIENT
Water/Aqua, Triethoxycaprylylsilane, 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, Dimethicone, 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 [ May Containt +/-: Titanium Dioxide, Iron Oxides/ CI 77492/ CI 77491/ CI 77499]
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SABLE LONG WEAR MAKEUP BROAD SPECTRUM SPF 20
octisalate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-337 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 6.82 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) 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) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) 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) ICODEXTRIN (UNII: 2NX48Z0A9G) RICE BRAN (UNII: R60QEP13IC) ROSEMARY (UNII: IJ67X351P9) 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) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) LENTINULA EDODES MYCELIUM (UNII: CU2S39TB8O) SWEET POTATO (UNII: M9WGG9Z9GK) CENTELLA ASIATICA (UNII: 7M867G6T1U) BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90) CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERRIC OXIDE RED (UNII: 1K09F3G675) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-337-02 1 in 1 BOX 07/07/2015 1 NDC:68828-337-01 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 07/07/2015 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(68828-337)
