YES TO GRAPEFRUIT CC CREAM - LIGHT/MEDIUM- 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.

----------

YES TO GRAPEFRUIT CC CREAM - LIGHT/MEDIUM

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, Helianthus Annuus (Sunflower) Seed Oil, Glycerin, Cetearyl Alcohol, Caprylic/Capric Triglyceride, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Magnesium Aluminum Silicate, Propanediol, Coco-Glucoside, Zea Mays (Corn) Starch*, Citrus Grandis (Grapefruit) Peel Extract*, Moringa oleifera seed oil, Evodia Rutaecarpa Fruit Extract, Phenethyl Alcohol, Cetyl Alcohol, Fragrance, Glyceryl Caprylate, Xanthan Gum, Glyceryl Isostearate, Hydrated Silica, Glycine Soja (Soybean) Oil, Tocopherol, Cyamopsis Tetragonoloba (Guar) Gum*, Disodium Carboxyethyl Siliconate, Citric Acid, Limonene, Aluminum Hydroxide, Polyhydroxystearic Acid, Trihydroxystearin, Triethoxycaprylylsilane, Potassium Hydroxide, Titanium Dioxide, Iron Oxides. * 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.

Principal Display Panel

carton

Image Componentscomponent

YES TO GRAPEFRUIT CC CREAM - LIGHT/MEDIUM 
zinc oxide, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51514-0324
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)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ALMOND OIL (UNII: 66YXD4DKO9)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
PROPANEDIOL (UNII: 5965N8W85T)  
COCO GLUCOSIDE (UNII: ICS790225B)  
STARCH, CORN (UNII: O8232NY3SJ)  
PHENETHYL ALCOHOL (UNII: ML9LGA7468)  
LIMONENE, (+/-)- (UNII: 9MC3I34447)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
GRAPEFRUIT (UNII: O82C39RR8C)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
XANTHAN GUM (UNII: TTV12P4NEE)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
MORINGA OLEIFERA SEED OIL (UNII: REM6A5QMC0)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TETRADIUM RUTICARPUM FRUIT (UNII: Q413WWJ3X9)  
SOYBEAN OIL (UNII: 241ATL177A)  
TOCOPHEROL (UNII: R0ZB2556P8)  
GUAR GUM (UNII: E89I1637KE)  
DISODIUM CARBOXYETHYL SILICONATE (UNII: 4U4C79679G)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
GRAPEFRUIT PEEL (UNII: 3582N05Q44)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEFRUITImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51514-0324-150 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/19/2013
Labeler - Autumn Harp, Inc (064187883)
Establishment
NameAddressID/FEIBusiness Operations
Autumn Harp, Inc064187883manufacture(51514-0324)

Revised: 10/2013
Document Id: 6e4cd232-2f23-4b65-9158-70e358035e3a
Set id: 1f555225-9c6d-4d1c-9c81-05f6caa309a3
Version: 1
Effective Time: 20131025
 
Autumn Harp, Inc