VITA WATER DROP CC- titanium dioxide, octinoxate, zinc oxide cream 
SKINFOOD CO., LTD.

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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ACTIVE INGREDIENT

Active ingredient: TITANIUM DIOXIDE 7.188%, ETHYLHEXYL METHOXYCINNAMATE 7.00%, ZINC OXIDE 0.985%

INACTIVE INGREDIENT

Inactive ingredient:
WATER, CYCLOPENTASILOXANE, CAPRYLYL METHICONE, METHYL TRIMETHICONE, GLYCERIN, PEG-10 DIMETHICONE, PHENYL TRIMETHICONE, ARBUTIN, DIPROPYLENE GLYCOL, TALC, DISTEARDIMONIUM HECTORITE, SODIUM CHLORIDE, BETAINE, CAPRYLYL GLYCOL, PYRUS MALUS (APPLE) FRUIT EXTRACT, DAUCUS CAROTA SATIVA (CARROT) ROOT EXTRACT, SOLANUM LYCOPERSICUM (TOMATO) FRUIT EXTRACT, CUCURBITA PEPO (PUMPKIN) FRUIT EXTRACT, BRASSICA OLERACEA ITALICA (BROCCOLI) EXTRACT, BRASSICA OLERACEA CAPITATA (CABBAGE) LEAF EXTRACT, ASPARAGUS OFFICINALIS STEM EXTRACT, APIUM GRAVEOLENS (CELERY) EXTRACT, EUTERPE OLERACEA FRUIT EXTRACT, RUBUS IDAEUS (RASPBERRY) FRUIT EXTRACT, FRAGARIA CHILOENSIS (STRAWBERRY) FRUIT EXTRACT, VACCINIUM MACROCARPON (CRANBERRY) FRUIT EXTRACT, POLYGLYCERYL-6 POLYRICINOLEATE, DIMETHICONE, METHICONE, DIMETHICONE CROSSPOLYMER, SILICA SILYLATE, ASCORBYL TETRAISOPALMITATE, DIMETHICONE/METHICONE COPOLYMER, ARACHIS HYPOGAEA (PEANUT) OIL, RETINYL PALMITATE, ADENOSINE, TRIMETHYLSILOXYSILICATE, TRIETHOXYCAPRYLYLSILANE, TOCOPHERYL ACETATE, TOCOPHEROL, PHENOXYETHANOL, FRAGRANCE, IRON OXIDES (CI 77492), IRON OXIDES (CI 77491), IRON OXIDES (CI 77499)

PURPOSE

PURPOSE: Sunscreen

WARNINGS

Warning:
Skin Cancer/Skin Aging Alert
Spending time in the sun increases your risk of skin cancer and early skin aging.
This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

USE

USE:
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

DIRECTIONS

DIRECTIONS:
Apply liberally 15 minutes before sun exposure.
Reapply at least every 2 hours. Sun Protection Measures.
Spending time in the sun increases your risk of skin cancer and early skin aging.
To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m. - 2 p.m.
Wear long-sleeved shirts, pants, hats, and sunglasses.
Children under 6 months of age: Ask a doctor.

Other information

Other information:
Protect the product in this container from excessive heat and direct sun.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

VITA WATER DROP CC 
titanium dioxide, octinoxate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76214-048
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.15 g  in 30 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.1 g  in 30 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.29 g  in 30 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76214-048-0130 g in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/01/2014
Labeler - SKINFOOD CO., LTD. (690324173)
Registrant - SKINFOOD CO., LTD. (690324173)
Establishment
NameAddressID/FEIBusiness Operations
SKINFOOD CO., LTD.690324173manufacture(76214-048)

Revised: 11/2014
Document Id: 409ae570-45a5-4ad3-82bc-f19a53e4fc16
Set id: 571031fa-ed21-43c2-b24b-d2094606ca8f
Version: 1
Effective Time: 20141103
 
SKINFOOD CO., LTD.