YES TO CUCUMBERS NATURAL SUNSCREEN SPF 30- 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 30

Active Ingredients

Zinc Oxide (11%)  Titanium Dioxide (6.2%)

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 of 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 Mesaure  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 measures including: Limit time in the sun, especially from 10 am - 2 pm. Wear long-sleeved shirts, pants, hats, and sun-glasses

Inactive Ingredients

Water, Ethylhexyl Palmitate, Hydrogenated Methyl Abietate, Glyceryl Stearate Citrate, Glycerin, Magnesium Aluminum Silicate, Aluminum Hydroxide, Cetearyl Alcohol, Phenethyl Alcohol, Sodium Magnesium Silicate, Glyceryl Caprylate, Xanthan Gum, Fragrance, Hydrated Silica, Triethoxycaprylylsilane, Tocopherol, Aloe Barbadensis Leaf Juice, Alcohol, Cumumis 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 30 
zinc oxide, titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51514-0318
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE11.0 g  in 100 g
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide6.2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
HYDROGENATED METHYL ABIETATE (UNII: A23O709X8O)  
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
GLYCERIN (UNII: PDC6A3C0OX)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
PHENETHYL ALCOHOL (UNII: ML9LGA7468)  
LAPONITE (UNII: D703131383)  
XANTHAN GUM (UNII: TTV12P4NEE)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
CUCUMBER (UNII: YY7C30VXJT)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
TOCOPHEROL (UNII: R0ZB2556P8)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALCOHOL (UNII: 3K9958V90M)  
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)  
potassium hydroxide (UNII: WZH3C48M4T)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51514-0318-185 g in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/01/2013
Labeler - Autumn Harp, Inc. (064187883)
Establishment
NameAddressID/FEIBusiness Operations
Autumn Harp, Inc.064187883manufacture(51514-0318)

Revised: 9/2013
Document Id: d806c4c7-0eaa-47bf-a424-0bdfe08f3a43
Set id: 82caeed8-306f-49e3-adf4-31017eb6ce35
Version: 1
Effective Time: 20130930
 
Autumn Harp, Inc.