NDC | 68828-133-01, 68828-133-02 |
Set ID | 4d8dd060-77df-4529-a68a-2f6597ca673c |
Category | HUMAN OTC DRUG LABEL |
Packager | Jafra Cosmetics International Inc |
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
Reapply at least every 2 hours
Use a water resistant sunscreen if swimming or sweating
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 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
Inactive ingredients
Water/Aqua, Butylene Glycol, Sorbitan Laurate, Hydroxyethylcellulose, Acetyl Dipeptide-1, Cetyl Ester, Pentylene Glycol, Cetearyl Alcohol, Coco-glucoside, Algae Extract, Pullulan, Niacinamide, Hydrolyzed Soy Protein, Zea Mays (Corn) Kernel Extract, Xanthan Gum, Sodium Hyaluronate, Trehalose, Sodium PCA, Polyquaternium-51, Urea, Glycerin, Avena Sativa (Oat) Kernel Extract, Cocos Nucifera (Coconut) Oil, Cucumis Sativus (Cucumber) Fruit Extract, Santalum Album (Sandalwood) Wood Extract, Rose Extract, Pyrus Malus, Hydrolyzed Soy Protein, Zea (Apple) Fruit Extract, Passiflora Incarnata Fruit Extract, Prunus Armeniaca (Apricot) Fruit Extract, Rubus Idaeus (Raspberry) Fruit Extract, Cananga Odorata Flower Extract, Cucumis Melo Cantalupensis Fruit Extract, C20-22 Alkyl Phosphate, C20-22 Alcohols, Caprylic/Capric Triglyceride, Alaria Esculenta Extract, Yeast Amino Acids, Tricalcium Phosphate, Morinda Citrifolia Extract, Carica Papaya Extract, Glycyrrhiza Glabra (Licorice) Extract, Pichia Anomala Extract, Tripleurospermum Maritima Extract, Microcrystalline Cellulose, Cellulose Gum, Dipotassium Glycyrrhizate, Glycine Soja (Soybean) Oil, Arnica Montana Flower Extract, Tocopheryl, Trisodium EDTA, PEG-4 Laurate, Iodopropynyl Butlcarbamate, Menthyl Lactate, Benzylidene Dimethoxydimethylindanone, Polyacrylamide, C13-14 Isoparaffin, Laureth-7. - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FACE LIFT BROAD SPECTRUM SPF 20 JAFRA PRO
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-133 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 5 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 7 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) SORBITAN MONOLAURATE (UNII: 6W9PS8B71J) HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP) N-ACETYL DIPEPTIDE-1 (UNII: HA41Z1UF8D) CETYL ESTERS WAX (UNII: D072FFP9GU) PENTYLENE GLYCOL (UNII: 50C1307PZG) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) COCO GLUCOSIDE (UNII: ICS790225B) PULLULAN (UNII: 8ZQ0AYU1TT) NIACINAMIDE (UNII: 25X51I8RD4) CORN (UNII: 0N8672707O) HYALURONATE SODIUM (UNII: YSE9PPT4TH) TREHALOSE (UNII: B8WCK70T7I) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) UREA (UNII: 8W8T17847W) GLYCERIN (UNII: PDC6A3C0OX) OAT (UNII: Z6J799EAJK) COCONUT OIL (UNII: Q9L0O73W7L) CUCUMBER (UNII: YY7C30VXJT) SANDALWOOD (UNII: 3641YW25N2) PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P) APRICOT (UNII: 269CJD5GZ9) RASPBERRY (UNII: 4N14V5R27W) CANANGA ODORATA FLOWER (UNII: 76GTF6Z97M) CANTALOUPE (UNII: 8QF5D5H6UH) C20-22 ALKYL PHOSPHATE (UNII: L4VKP0Y7RP) C20-22 ALCOHOLS (UNII: O4M0347C6A) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ALARIA ESCULENTA (UNII: EJ9JK8J58D) TRICALCIUM PHOSPHATE (UNII: K4C08XP666) MORINDA CITRIFOLIA LEAF (UNII: 7UOL7P5FF5) PAPAYA (UNII: KU94FIY6JB) LICORICE (UNII: 61ZBX54883) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) XANTHAN GUM (UNII: TTV12P4NEE) DMDM HYDANTOIN (UNII: BYR0546TOW) PANTHENOL (UNII: WV9CM0O67Z) EDETATE TRISODIUM (UNII: 420IP921MB) PEG-4 LAURATE (UNII: AYF4VM3N1Z) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I) BENZYLIDENE DIMETHOXYDIMETHYLINDANONE (UNII: 75HIF3C97L) POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) LAURETH-7 (UNII: Z95S6G8201) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-133-02 1 in 1 CARTON 04/15/2013 1 NDC:68828-133-01 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 04/15/2013 Labeler - Jafra Cosmetics International Inc (041676479) Registrant - Jafra Cosmetics International Inc (041676479) Establishment Name Address ID/FEI Business Operations Jafra Manufacturing, S.A. de C.V. 814732061 manufacture(68828-133)