Wet N Wild Coloricon Bronzer: Package Insert and Label Information

WET N WILD COLORICON BRONZER- octinoxate and oxybenzone powder
Markwins Beauty Products, 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.

Active Ingredients
Octinoxate 5%
Oxybenzone 1.5%
Use • Helps prevent sunburn 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 and ask a 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
• reapply at least every 2 hours
• use a water resistant sunscreen if swimming or sweating
• children under 6 months: Ask a doctor
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) Package Label

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 DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (OCTINOXATE) OCTINOXATE 5 g in 100 g OXYBENZONE (OXYBENZONE) OXYBENZONE 1.5 g in 100 g

Inactive Ingredients Ingredient Name Strength MICA BORON NITRIDE CYCLOMETHICONE 5 PHENYL TRIMETHICONE CAPRYLYL GLYCOL DIMETHICONE ALUMINUM OXIDE LEVOMENOL CAPRYLHYDROXAMIC ACID GLYCERIN FERRIC OXIDE RED TITANIUM DIOXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:12027-103-46 13 g in 1 CONTAINER None

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	Operations
Markwins International Corp.		544845621	manufacture

Revised: 11/2011 Markwins Beauty Products, Inc