WET N WILD COLORICON BRONZER- octinoxate oxybenzone powder

wet n wild by

Drug Labeling and Warnings

wet n wild by is a Otc medication manufactured, distributed, or labeled by Markwins Beauty Products, Inc , Markwins International Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients
Octinoxate 5%
Oxybenzone 1.5%

INDICATIONS & USAGE

Use Helps prevent sunburn

WARNINGS

Warnings
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 help prevent sunburn, not skin cancer or skin aging.

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

Stop use and ask a doctor
if rash occurs

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.
If product is swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Directions
apply liberally 15 minutes before sun exposure
reapply at least every 2 hours
use a water resistant sunscreen if swimming or sweating
children under 6 months: Ask a doctor

INACTIVE INGREDIENT

Inactive Ingredients/Ingredients inactifs
Mica, Boron Nitride, Cyclopentasiloxane, Phenyl Trimethicone, Nylon-12, Caprylyl Glycol, Methicone, Dimethicone Crosspolymer, Alumina, Bisabolol, Caprylhydroxamic Acid, Glycerin, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol
(MAY CONTAIN/PEUT CONTENIR): Iron Oxides/CI 77491, CI 77492, CI 77499, Manganese Violet/CI 77742, Titanium Dioxide/CI 77891)

PRINCIPAL DISPLAY PANEL

Package Label

INGREDIENTS AND APPEARANCE

WET N WILD  COLORICON BRONZER
octinoxate oxybenzone powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 12027-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	5 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	1.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MICA (UNII: V8A1AW0880)
BORON NITRIDE (UNII: 2U4T60A6YD)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALUMINUM OXIDE (UNII: LMI26O6933)
LEVOMENOL (UNII: 24WE03BX2T)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
GLYCERIN (UNII: PDC6A3C0OX)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 12027-103-46	13 g in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	12/01/2011

Labeler - Markwins Beauty Products, Inc (135407760)

Establishment
Name	Address	ID/FEI	Business Operations
Markwins International Corp.		544845621	manufacture