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

Wet n Wild Fergie BB Cream SPF 15 by

Drug Labeling and Warnings

Wet n Wild Fergie BB Cream SPF 15 by is a Otc medication manufactured, distributed, or labeled by Markwins Beauty Products Inc., Physicians Formula Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Titanium Dioxide 3.8%

INDICATIONS & USAGE

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

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 INGREDIENT

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]

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.8 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
1,3-BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
ALCOHOL (UNII: 3K9958V90M)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
SQUALANE (UNII: GW89575KF9)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALUMINUM OXIDE (UNII: LMI26O6933)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CUCUMBER (UNII: YY7C30VXJT)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
PANTHENOL (UNII: WV9CM0O67Z)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
STEARIC ACID (UNII: 4ELV7Z65AP)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 12027-105-11	30 mL in 1 TUBE

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	Business Operations
Physicians Formula Inc		825048945	manufacture(12027-105)