NDC | 68807-301-11 |
Set ID | cd5beee7-d8f5-4e1c-b990-98db641a20a2 |
Category | HUMAN PRESCRIPTION DRUG LABEL |
Packager | Temmentec Ag |
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 age
Inactive 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, Cholsteryl 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 (CI 14700), Yellow 5 (CI 19140), Gold
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INGREDIENTS AND APPEARANCE
LA PRAIRIE SWITZERLAND CELLULAR RADIANCE EMULSION
avobenzone, octinoxate, octisalate creamProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68807-301 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3.0 kg in 100 kg OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 kg in 100 kg OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5.0 kg in 100 kg Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68807-301-11 78.4 kg in 1 DRUM Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/01/2009 Labeler - Temmentec Ag (480586411) Registrant - Temmentec Ag (480586411) Establishment Name Address ID/FEI Business Operations Temmentec Ag 480586411 manufacture