YES TO BLUEBERRIES DAILY REPAIRING MOISTURIZER SPF30- 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 Blueberries Daily Repairing Moisturizer SPF30

Drug Facts

Active Ingredients

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

Purpose

Sunscreen

Uses: Helps prevent sunburn • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings:

For external use only •  Do not use on damaged or broken skin • When using this product keep out of eyes.  Rinse with water to remove • Stop use and ask Doctor if rash occurs • Keep out of reach of children.  If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply at least every two hours. Children under 6 months: Ask a doctor.

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.

Inactive Ingredients

Water, Ethylhexyl Palmitate, Hydrogenated Methyl Abietate, Glyceryl Stearate Citrate, Glycerin, Magnesium Aluminum Silicate, Aluminum Hydroxide, Cetearyl Alcohol, Phenethyl Alcohol, Alcohol, Sodium Magnesium Silicate, Glyceryl Caprylate, Vaccinium Cyanococcus (Blueberry) Fruit Juice, Xanthan Gum, Hydrated Silica, Triethoxycaprylylsilane, Tocopherol, Limonene, Fragrance, Onopordum Acanthium Flower/Leaf/Stem Extract, Linalool, Aloe Barbadensis Leaf Juice*, Linalool, Citral, Geraniol, Citronellol. * Certified Organic Ingredient

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YES TO BLUEBERRIES DAILY REPAIRING MOISTURIZER SPF30 
zinc oxide, titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51514-0322
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE11.0 mg  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE6.2 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
WATER (UNII: 059QF0KO0R)  
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)  
ALCOHOL (UNII: 3K9958V90M)  
LAPONITE (UNII: D703131383)  
LOWBUSH BLUEBERRY (UNII: G90PX41VP0)  
XANTHAN GUM (UNII: TTV12P4NEE)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
TOCOPHEROL (UNII: R0ZB2556P8)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
ONOPORDUM ACANTHIUM FLOWERING TOP (UNII: 475866K8C4)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
LINALOOL, (+)- (UNII: F4VNO44C09)  
SOYBEAN OIL (UNII: 241ATL177A)  
CITRAL (UNII: T7EU0O9VPP)  
GERANIOL (UNII: L837108USY)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
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:51514-0322-141 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/22/2013
Labeler - Autumn Harp, Inc. (064187883)
Establishment
NameAddressID/FEIBusiness Operations
Autumn Harp, Inc.064187883manufacture(51514-0322)

Revised: 10/2013
Document Id: a27a7f76-5ba8-4258-a9fa-a346075c5cd3
Set id: 0dbdea5b-6d4c-4c0f-8e82-e02c287088a5
Version: 1
Effective Time: 20131009
 
Autumn Harp, Inc.