NDC | 10096-0281-1, 10096-0281-2 |
Set ID | dc756ca2-9a84-4778-bdbc-8da0d92eff30 |
Category | HUMAN OTC DRUG LABEL |
Packager | New Avon LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions
• apply liberally 15 minutes before sun exposure
• children under 6 months of age: ask a doctor
• reapply at least every 2 hours
• use a water resistant sunscreen if swimming or sweating• 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 10 a.m. – 2 p.m.
• wear long-sleeved shirts, pants, hats, and sunglasses - STORAGE AND HANDLING
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INACTIVE INGREDIENT
Inactive ingredients: Water/Eau, Butylene Glycol, Ethylhexyl Palmitate, Cyclopentasiloxane, Cetyl PEG/PPG-10/1 Dimethicone, Glyceryl
Stearate, PEG-40 Stearate, Silica, Steareth-2, Stearic Acid, Euphorbia Cerifera (Candelilla) Wax/Cire De Candelilla, Dimethicone, PEG-10
Dimethicone, Magnesium Aluminum Silicate, Triethanolamine, Glycerin, Imidazolidinyl Urea, Methylparaben, Alumina, Methicone, Xanthan Gum, Hydrolyzed Elastin, Ethylparaben, Kaolin, Punica Granatum Fruit Juice, Saccharomyces Lysate Extract, Sodium Hexametaphosphate, Tetrasodium EDTA, Zinc PCA, Phenyl Trimethicone, Beeswax/Cire D'abeille, Yeast Extract/Extrait De Levure, Salix Nigra (Willow) Bark Extract, Tocopheryl Acetate, Retinyl Palmitate, Sodium PCA, Olea Europaea (Olive) Leaf Extract, Urea, Silica Dimethyl Silylate, Hyaluronic Acid, Trehalose, Polyquaternium-51, Sodium Hyaluronate, Daucus Carota Sativa (Carrot) Root Extract, Tocopherol, Atelocollagen, Sodium Chondroitin Sulfate. May Contain: Iron Oxides, Titanium Dioxide/CI 77891, Mica/CI 77019. - QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MARK GOT THE GOODS MULTI-BENEFIT FOUNDATION
octinoxate, titanium dioxide, oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10096-0281 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 74.9 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 26 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 20 mg in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10096-0281-2 1 in 1 CARTON 1 NDC:10096-0281-1 30 mL in 1 BOTTLE, PUMP; 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 05/22/2012 Labeler - New Avon LLC (080143520) Establishment Name Address ID/FEI Business Operations Avon Products, Inc. 005149471 manufacture(10096-0281)