NDC | 59614-301-01, 59614-301-02 |
Set ID | 0daa1d8f-4522-4a1a-9ebf-78907be6aa9d |
Category | HUMAN OTC DRUG LABEL |
Packager | Juvena Produits de Beaute |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
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ACTIVE INGREDIENT
Active Ingredients Purpose
Avobenzone 3.0% Sunscreen
Octinoxate 7.5% Sunscreen
Octisalate 5.0% Sunscreen
Warnings
-for external use only
-When using this product keep out of eyes
-Rinse with water to remove
-Stop use and ask a doctor if rash or irritation develops and lasts
-keep out of reach of children
-Do not use on infants under 6 months of age.Uses
-helps prevent sunburn
-for skin that burns easily
-provides moderate protection against sunburn
-higher SPF gives more sunburn protection
Directions
-For external use only
-when using this product keep out of eyes
-rinse with water to remove
-stop use and ask doctor if rash or irritation develops and lasts
-keep out of reach of children
-do not use on infants under 6 months of ageInactive Ingredients: Water (Aqua), C12-15 Alkyl Ethylhexanoate, Cetyl Alcohol, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Sea Water (Maris Aqua), Dimethicone, Behenyl Alcohol, Stearyl Alcohol, Butylene Glycol, Propylene Glycol, Caprylic/Capric Triglyceride, Cyclopentasiloxane, Batyl Alcohol, Glycoproteins, Panax Ginseng Root Extract, Equisetum Arvense (Horsetail) Extract, Phytosterols, Silicornia Herbacea Extract, Niacinamide, Hydrolyzed Oat Protein, Alpinia Galang Leaf Extract, Quartz, Disodium Adenosine Triphosphate, Tocopherol, Carica Papaya (Papaya) Fruit Extract, Cholesteryl Nonanoate, Cimicifuga Racemosa Root Extract, Copper Gluconate, PEG-20 Phytosterol, Actinidia Polygama Fruit Extract, Acetyl Heptapeptide-Gold, Cholesteryl Oleate, Dimethylmethoxy Chromanyl Palmitate, Corallina Officinalis Extract, Carbomer, Chlosteryl Stearate, Acrylates Copolymer, Boswellia Serrata Extract, Ammonium Acryloyldimethltaurate/Beheneth-25 Methacrylate Crosspolymer, Phormidium Persicinum Extract, Caprylyl Glycol, Dextran, Magnesium Asparate Glyceryl Stearate, Disodium EDTA, Xanthan Gum, BHT, Fragrance (Parfum), Linalool, Hexyl Cinnamal, Hydroxycitronellal, Alpha-Isomethyl Ionone, Geraniol, Citronellol, Benzyl Benzoate, Butylphenyl Methylpropional, Evernia Furfuracea (Treemoss) Extract, Eugenol, Benzyl Salicylate, Limonene, Phenoxyethanol, Sorbia Acid, Methylparaben, Mica, Titanium Dioxide (Ci 77891), Red (14700), Yellow 5 (CI 19140), Gold - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LA PRAIRIE SWITZERLAND CELLULAR RADIANCE EMULSION
avobenzone, octinoxate, octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59614-301 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3.0 mL in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 mL in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5.0 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59614-301-02 1 in 1 BOX 1 NDC:59614-301-01 50 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/01/2009 Labeler - Juvena Produits de Beaute (315053785) Registrant - Juvena Produits de Beaute (315053785) Establishment Name Address ID/FEI Business Operations Juvena Produits de Beaute 315053785 manufacture