Wet N Wild Fergie BB Cream SPF 15: Package Insert and Label Information

WET N WILD FERGIE BB CREAM SPF 15- titanium dioxide cream
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 Ingredient

Titanium Dioxide 3.8%

Use
Helps prevent sunburn

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

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 prevent sunburn, not skin cancer or early 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.

Inactive Ingredients

Water/Eau, Cyclopentasiloxane, Butylene Glycol, Caprylic/Capric Triglyceride, Triethylhexanoin, Cyclohexasiloxane, Alcohol Denat., Cetyl PEG/PPG-10/1 Dimethicone, Squalane, Polyglyceryl-4 Isostearate, Disteardimonium Hectorite, PEG-32, Aloe Barbadensis Leaf Juice, Alumina, Calcium Aluminum Borosilicate, Caprylyl Glycol, Cucumis Sativus (Cucumber) Fruit Extract, Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Disodium EDTA, Ethylhexylglycerin, Glycerin, Hexylene Glycol, Panthenol, Retinyl Palmitate, Stearic Acid, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Sodium Dehydroacetate, Phenoxyethanol, [+/- (MAY CONTAIN/PEUT CONTENIR): Mica, Titanium Dioxide/CI 77891, Iron Oxides/CI 77491, CI 77492, CI 77499]

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WET N WILD FERGIE BB CREAM SPF 15 titanium dioxide cream

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:12027-105 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 3.8 g in 100 mL

Inactive Ingredients Ingredient Name Strength WATER CYCLOMETHICONE 5 1,3-BUTYLENE GLYCOL MEDIUM-CHAIN TRIGLYCERIDES TRIETHYLHEXANOIN CYCLOMETHICONE 6 ALCOHOL CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) SQUALANE POLYGLYCERYL-4 ISOSTEARATE DISTEARDIMONIUM HECTORITE POLYETHYLENE GLYCOL 1450 ALOE VERA LEAF ALUMINUM OXIDE CALCIUM ALUMINUM BOROSILICATE CAPRYLYL GLYCOL CUCUMBER DIMETHICONE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) EDETATE DISODIUM ETHYLHEXYLGLYCERIN GLYCERIN HEXYLENE GLYCOL PANTHENOL VITAMIN A PALMITATE STEARIC ACID TETRAHEXYLDECYL ASCORBATE .ALPHA.-TOCOPHEROL ACETATE SODIUM DEHYDROACETATE PHENOXYETHANOL MICA FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:12027-105-11 30 mL in 1 TUBE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 05/31/2013

Labeler — Markwins Beauty Products Inc. (135407760)

Registrant — Markwins Beauty Products Inc. (135407760)

Establishment
Name	Address	ID/FEI	Operations
Physicians Formula Inc		825048945	manufacture (12027-105)

Revised: 05/2013 Markwins Beauty Products Inc.