NDC | 68828-400-01, 68828-400-02 |
Set ID | 7e12a7d2-fbb5-4118-b85a-5386e7cf736a |
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 minths: 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 10a.m. - 2p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses
-
INACTIVE INGREDIENT
Water/Aqua, Polyglycery-3 Methylglucose Distearate, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Glyceryl Stearate, Glycerin, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Ipomoea Digitata (Fingerleaf Morning Glory) Extract, Withania Somniferia (Winter Cherry) Extract, Vigna Radiata (Mung Bean) Extract, Trisodium EDTA, Panthenol, Tocopheryl Acetate, PEG-4 Laurate, Iodopropynyl Butylcarbamate, Biasacchardie Gum-4, Chondrus Crispus (Carrageenan) Extract, Chamomilla Recutita (Matricaria) Extact, Morus Alba Extract, Lonicera Caprifolium (Honeysuckle) Flower Extract, Potassium Sorbate, Fragrance/Parfum
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DAY CARE FOR HANDS BROAD SPECTRUM SPF 15 JAFRA
avobenzone, octinoxate, octisalate, oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-400 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 75 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 75 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4 g in 75 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 2 g in 75 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) LAURETH-7 (UNII: Z95S6G8201) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) GLYCERIN (UNII: PDC6A3C0OX) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) HEXYLENE GLYCOL (UNII: KEH0A3F75J) EDETATE TRISODIUM (UNII: 420IP921MB) PANTHENOL (UNII: WV9CM0O67Z) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PEG-4 LAURATE (UNII: AYF4VM3N1Z) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90) CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78) MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-400-02 1 in 1 BOX 06/14/2016 1 NDC:68828-400-01 75 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 06/14/2016 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(68828-400)