Label: YES TO CUCUMBERS NATURAL SUNSCREEN SPF 30 STICK- zinc oxide, titanium dioxide stick
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Contains inactivated NDC Code(s)
NDC Code(s): 51514-0315-1 - Packager: Autumn Harp, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 25, 2013
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- Active Ingredient
- Purpose
- Uses
- Warnings:
- Directions
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Sun Protection Measure
Spending time 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 protection 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
Beeswax, Ethylhexyl Palmitate, Carthamus Tinctorius (Safflower) Seed Oil, Ethyl Palmate*, Theobroma Cacao (Cocoa) Seed Butter, Butyrospermum Parkii (Shea) Butter, Fragrance, Polyglyceryl-3 Diisostearate, Aluminum Hydroxide, Helianthus Annuus (Sunflower) Seed Oil, Hydrated Silica, Triethoxycaprylylsilane, Tocopherol, Cucumis Sativus (Cucumber) Seed Extract*. * Certified Organic Ingredient
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INGREDIENTS AND APPEARANCE
YES TO CUCUMBERS NATURAL SUNSCREEN SPF 30 STICK
zinc oxide, titanium dioxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51514-0315 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 10.8 g in 100 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 4.9 g in 100 g Inactive Ingredients Ingredient Name Strength YELLOW WAX (UNII: 2ZA36H0S2V) SAFFLOWER OIL (UNII: 65UEH262IS) ETHYLHEXYL PALMITATE (UNII: 2865993309) ETHYL PALMATE (UNII: PY7890FR5M) COCOA BUTTER (UNII: 512OYT1CRR) SHEA BUTTER (UNII: K49155WL9Y) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CUCUMBER (UNII: YY7C30VXJT) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) SUNFLOWER OIL (UNII: 3W1JG795YI) HYDRATED SILICA (UNII: Y6O7T4G8P9) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) TOCOPHEROL (UNII: R0ZB2556P8) SOYBEAN OIL (UNII: 241ATL177A) cucumber seed (UNII: BT3S9L53JK) 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:51514-0315-1 15 g in 1 CONTAINER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 01/11/2013 Labeler - Autumn Harp, Inc. (064187883) Establishment Name Address ID/FEI Business Operations Autumn Harp, Inc. 064187883 manufacture(51514-0315)