YES TO GRAPEFRUIT MOISTURIZER WITH SPF15- zinc oxide, titanium dioxide lotion

Yes To Grapefruit Moisturizer with SPF15 by

Drug Labeling and Warnings

Yes To Grapefruit Moisturizer with SPF15 by is a Otc medication manufactured, distributed, or labeled by Autumn Harp, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS AND PRECAUTIONS

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

INGREDIENTS AND APPEARANCE

YES TO GRAPEFRUIT MOISTURIZER WITH SPF15 
zinc oxide, titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51514-0317
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	3.2 mg  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.9 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score
Shape		Size
Flavor	GRAPEFRUIT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51514-0317-1	41 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/14/2012

Labeler - Autumn Harp, Inc. (064187883)

Establishment
Name	Address	ID/FEI	Business Operations
Autumn Harp, Inc.		064187883	manufacture(51514-0317)