YES TO CUCUMBERS NATURAL SUNSCREEN SPF 40 KIDS- zinc oxide, titanium dioxide lotion 
Autumn Harp, Inc.

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.

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Yes To Cucumbers Natural Sunscreen SPF 40 Kids

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

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YES TO CUCUMBERS NATURAL SUNSCREEN SPF 40 KIDS 
zinc oxide, titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51514-0316
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE11.7 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51514-0316-185 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35212/30/2012
Labeler - Autumn Harp, Inc. (064187883)
Establishment
NameAddressID/FEIBusiness Operations
Autumn Harp, Inc.064187883manufacture(51514-0316)

Revised: 9/2013
Document Id: 2d684392-63bd-4cc6-8412-7d12b244680b
Set id: 11da3730-7224-40f5-84b1-d7f27eb70bf6
Version: 1
Effective Time: 20130926
 
Autumn Harp, Inc.