Your browser does not support JavaScript! WET N WILD FERGIE BB CREAM SPF 15 (TITANIUM DIOXIDE) CREAM [MARKWINS BEAUTY PRODUCTS INC.]
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WET N WILD FERGIE BB CREAM SPF 15 (titanium dioxide) cream
[Markwins Beauty Products Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:12027-105
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE3.8 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 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
 
Markwins Beauty Products Inc.

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