Label: WET N WILD FERGIE BB CREAM SPF 15- titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 12027-105-11 - Packager: Markwins Beauty Products Inc.
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated May 31, 2013
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
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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 creamProduct 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)
