YES TO GRAPEFRUIT MOISTURIZER WITH SPF15- 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 Grapefruit Moisturizer with SPF15

Drug Facts

Active Ingredients

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

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 a 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 15 minutes before sun exposure.  Ues 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

Principal display panel

Image Components

image descriptionimage description

YES TO GRAPEFRUIT MOISTURIZER WITH SPF15 
zinc oxide, titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51514-0317
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)  
PHENETHYL ALCOHOL (UNII: ML9LGA7468)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
XANTHAN GUM (UNII: TTV12P4NEE)  
MORINGA OLEIFERA SEED OIL (UNII: REM6A5QMC0)  
LIMONENE, (+/-)- (UNII: 9MC3I34447)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
GRAPEFRUIT (UNII: O82C39RR8C)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
TOCOPHEROL (UNII: R0ZB2556P8)  
SOYBEAN OIL (UNII: 241ATL177A)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
GUAR GUM (UNII: E89I1637KE)  
CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T)  
SODIUM ASCORBATE (UNII: S033EH8359)  
PASSIFLORA INCARNATA FLOWER (UNII: K8F3G29S6Z)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorGRAPEFRUITImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51514-0317-141 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/14/2012
Labeler - Autumn Harp, Inc. (064187883)
Establishment
NameAddressID/FEIBusiness Operations
Autumn Harp, Inc.064187883manufacture(51514-0317)

Revised: 9/2013
Document Id: 758659ed-1519-4a12-b5ca-b510344486c5
Set id: dd644453-e0ef-49df-8619-e751c5b2ba38
Version: 1
Effective Time: 20130926
 
Autumn Harp, Inc.