YES TO CUCUMBERS NATURAL SUNSCREEN SPF 40 KIDS- zinc oxide, titanium dioxide lotion

Yes To Cucumbers Natural Sunscreen SPF 40 Kids by

Drug Labeling and Warnings

Yes To Cucumbers Natural Sunscreen SPF 40 Kids by is a Otc medication manufactured, distributed, or labeled by Autumn Harp, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Zinc Oxide (11.7%) Titanium Dioxide (5.5%)

Purpose

Sunscreen

Uses

Helps prevent sunburn Higher SPF gives more sunburn protection Provides high protection against sunburn

Warnings:

For external use only. When using this product avoid contact with eyes if contact occurs, rinse with water to remove. Stop use and ask Doctor if rash or irritation develops and lasts. Keep out or reach of children. If swallowed, get medical help or contact a Poison Control Center Immediately.

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.

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

Image Components

INGREDIENTS AND APPEARANCE

YES TO CUCUMBERS NATURAL SUNSCREEN SPF 40 KIDS 
zinc oxide, titanium dioxide lotion

Product 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)