YES TO CARROTS FRAGRANCE-FREE DAILY FACIAL MOISTURIZER SPF15- zinc oxide, titanium dioxide cream 
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 CARROTS FRAGRANCE-FREE DAILY FACIAL MOISTURIZER SPF15

Drug Facts

Active Ingredients:

Zinc Oxide (3.2%) Titanium Dioxide (2.9%)

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 10 am - 2 pm. Wear long-sleeved shirts, pants, hats, and sun-glasses.

Inactive Ingredients:

Water, Ethylhexyl Palmitate, Aloe Barbadensis Leaf Juice*, Helianthus Annuus (Sunflower) Seed Oil, Glycerin, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Magnesium Aluminum Silicate, Coco-Glucoside, Phenoxyethanol, Daucus Carota Sativa (Carrot) Root Extract*, Cucurbita Pepo (Pumpkin) Seed Oil*, Butyrospermum Parkii Butter, Cetyl Alcohol, Xanthan Gum, Cyamopsis Tetragonoloba (Guar) Gum*, Maris Limus Extract, Glycine Soja (Soybean) Oil, Tocopherol, Aluminum Hydroxide, Gluconolactone, Glyceryl Isostearate, Hydrated Silica, Polyhydroxystearic Acid, Sodium Benzoate, Triethoxycaprylylsilane, Calcium Gluconate, Citric Acid, Potassium Hydroxide.  * Certified Organic Ingredient

Questions? 1-888-92-Yes-To (1-888-929-3786) or visit www.yestocarrots.com

Other information

Protect this product from excessive heat and direct sun.

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YES TO CARROTS FRAGRANCE-FREE DAILY FACIAL MOISTURIZER SPF15 
zinc oxide, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51514-0326
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3.2 mg  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.9 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
glycerin (UNII: PDC6A3C0OX)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
ALMOND OIL (UNII: 66YXD4DKO9)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
COCO GLUCOSIDE (UNII: ICS790225B)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
GLUCONOLACTONE (UNII: WQ29KQ9POT)  
PUMPKIN SEED OIL (UNII: 6E5QR5USSP)  
SHEA BUTTER (UNII: K49155WL9Y)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SOYBEAN OIL (UNII: 241ATL177A)  
GUAR GUM (UNII: E89I1637KE)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CALCIUM GLUCONATE (UNII: SQE6VB453K)  
CARROT (UNII: L56Z1JK48B)  
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:51514-0326-150 mL in 1 PACKAGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/13/2013
Labeler - Autumn Harp, Inc (064187883)
Establishment
NameAddressID/FEIBusiness Operations
Autumn Harp, Inc064187883manufacture(51514-0326)

Revised: 1/2014
Document Id: 14a16b35-c86b-4368-806e-bc38c973c94a
Set id: 7b40e9ef-8e17-42c0-8ce6-c2028ad02e33
Version: 1
Effective Time: 20140103
 
Autumn Harp, Inc