Label: YES TO CUCUMBERS NATURAL SUNSCREEN SPF 40 KIDS- zinc oxide, titanium dioxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 51514-0316-1 - Packager: Autumn Harp, Inc.
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated September 26, 2013
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- 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
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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)
