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.

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Drug Facts

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]


image of product

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WET N WILD FERGIE BB CREAM SPF 15 
titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12027-105
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.8 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12027-105-1130 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/31/2013
Labeler - Markwins Beauty Products Inc. (135407760)
Registrant - Markwins Beauty Products Inc. (135407760)
Establishment
NameAddressID/FEIBusiness Operations
Physicians Formula Inc825048945manufacture(12027-105)

Revised: 5/2013
Document Id: 8ff3825c-aef3-4cef-a3fb-969cdbc9b71a
Set id: 41bbc937-9af5-4172-87b4-a8bb753facba
Version: 2
Effective Time: 20130531
 
Markwins Beauty Products Inc.