NDC | 51514-0316-1 |
Set ID | 11da3730-7224-40f5-84b1-d7f27eb70bf6 |
Category | HUMAN OTC DRUG LABEL |
Packager | Autumn Harp, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- Active Ingredient
- Purpose
- Uses
- Warnings:
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Directions
Apply liberally and evenly 15 minutes before sun exposure • reapply after 40 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours • children under 6 months of age, ask doctor
Sun Protection Measure Spendingtime in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun measures including: Limit time in the sun, especially from 10am - 2pm. Wear long-sleeved shirts, pants, hats, and sun-glasses.
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Inactive Ingredients
Water, Ethylhexyl Palmitate, Carthamus Tinctorius (Safflower) Seed Oil, Polyglyceryl-6 Polyricinoleate, Glycerin, Aluminum Hydroxide, Phenethyl Alcohol, Sodium Chloride, Glyceryl Caprylate, Polyglyceryl-10 Laurate, Triethoxycaprylylsilane, Fragrance, Hydrated Silica, Tocopherol, Alcohol, Aloe Barbadensis Leaf Juice, Cucumis Sativus (Cucumber) Seed Extract*, Camellia Sinensis (Green Tea) Leaf Extract, Citric Acid, Potassium Sorbate, Sodium Benzoate. * Certified Organic Ingredient
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
YES TO CUCUMBERS NATURAL SUNSCREEN SPF 40 KIDS
zinc oxide, titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51514-0316 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 11.7 g in 100 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 5.5 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ETHYLHEXYL PALMITATE (UNII: 2865993309) SAFFLOWER OIL (UNII: 65UEH262IS) POLYGLYCERYL-6 DIOLEATE (UNII: 062SZD3F3X) GLYCERIN (UNII: PDC6A3C0OX) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) PHENETHYL ALCOHOL (UNII: ML9LGA7468) SODIUM CHLORIDE (UNII: 451W47IQ8X) POLYGLYCERYL-10 LAURATE (UNII: MPJ2Q8WI8G) GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) CUCUMBER (UNII: YY7C30VXJT) HYDRATED SILICA (UNII: Y6O7T4G8P9) TOCOPHEROL (UNII: R0ZB2556P8) ALCOHOL (UNII: 3K9958V90M) ALOE VERA LEAF (UNII: ZY81Z83H0X) SOYBEAN OIL (UNII: 241ATL177A) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CUCUMBER SEED (UNII: BT3S9L53JK) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BENZOATE (UNII: OJ245FE5EU) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51514-0316-1 85 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 12/30/2012 Labeler - Autumn Harp, Inc. (064187883) Establishment Name Address ID/FEI Business Operations Autumn Harp, Inc. 064187883 manufacture(51514-0316)