BB TINTED TREATMENT 12-HOUR PRIMER BROAD SPECTRUM SPF 30 SUNSCREEN FAIR- titanium dioxide and zinc oxide liquid BB TINTED TREATMENT 12-HOUR PRIMER BROAD SPECTRUM SPF 30 SUNSCREEN LIGHT- titanium dioxide and zinc oxide liquid BB TINTED TREATMENT 12-HOUR PRIMER BROAD SPECTRUM SPF 30 SUNSCREEN MEDIUM- titanium dioxide and zinc oxide liquid BB TINTED TREATMENT 12-HOUR PRIMER BROAD SPECTRUM SPF 30 SUNSCREEN TAN- titanium dioxide and zinc oxide liquid BB TINTED TREATMENT 12-HOUR PRIMER BROAD SPECTRUM SPF 30 SUNSCREEN DEEP- titanium dioxide and zinc oxide liquid BB TINTED TREATMENT 12-HOUR PRIMER BROAD SPECTRUM SPF 30 SUNSCREEN RICH- titanium dioxide and zinc oxide liquid

BB Tinted Treatment 12-Hour Primer Broad Spectrum SPF 30 Sunscreen by

Drug Labeling and Warnings

BB Tinted Treatment 12-Hour Primer Broad Spectrum SPF 30 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Tarte, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Titanium Dioxide 4.55%	Sunscreen
Zinc Oxide 3.5%	Sunscreen

Uses

• Helps prevent sunburn.
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only.

Stop use and ask doctor if rash occurs.

Do not use on damaged or broken skin.

When using this product keep out of eyes. Rinse with water to remove.

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Shake before use.
• Apply liberally 15 minutes before sun exposure.
• Use a water resistant sunscreen if swimming or sweating.
• Reapply at least every 2 hours.
• Children under 6 months: Ask a doctor.
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • – Limit time in the sun, especially from 10 a.m.-2 p.m.
  • – Wear long-sleeved shirts, pants, hats and sunglasses

Other information

• Protect the product in this container from excessive heat and direct sunlight.
• You may report a serious adverse reaction to: tarte c/o Report Reaction, LLC, P.O. Box 22, Plainsboro, NJ 08536-0222.

Inactive Ingredients

Cyclopentasiloxane, isododecane, mica, polysilicone-11, polymethylsilsesquioxane, hexyl laurate, PEG-10 dimethicone, polyglyceryl-4 isostearate, stearic acid, cetyl PEG/PPG-10/1 dimethicone, alumina, triethoxycaprylylsilane, dipalmitoyl hydroxyproline, diamond powder, iron oxides.

SPL UNCLASSIFIED SECTION

Dist. by tarte, Inc.
New York, NY 10018.

PRINCIPAL DISPLAY PANEL - 10 mL Tube Carton - fair

tarte
high-performance naturals™

BB tinted treatment primer

Broad Spectrum
SPF 30 Sunscreen

net 10 mL / 0.33 Fl. Oz.

PRINCIPAL DISPLAY PANEL - 10 mL Tube Carton - light

tarte
high-performance naturals™

BB tinted treatment primer

Broad Spectrum
SPF 30 Sunscreen

net 10 mL / 0.33 Fl. Oz.

PRINCIPAL DISPLAY PANEL - 10 mL Tube Carton - medium

tarte
high-performance naturals™

BB tinted treatment primer

Broad Spectrum
SPF 30 Sunscreen

net 10 mL / 0.33 Fl. Oz.

PRINCIPAL DISPLAY PANEL - 10 mL Tube Carton - tan

tarte
high-performance naturals™

BB tinted treatment primer

Broad Spectrum
SPF 30 Sunscreen

net 10 mL / 0.33 Fl. Oz.

PRINCIPAL DISPLAY PANEL - 10 mL Tube Carton - deep

tarte
high-performance naturals™

BB tinted treatment primer

Broad Spectrum
SPF 30 Sunscreen

net 10 mL / 0.33 Fl. Oz.

PRINCIPAL DISPLAY PANEL - 10 mL Tube Carton - rich

tarte
high-performance naturals™

BB tinted treatment primer

Broad Spectrum
SPF 30 Sunscreen

net 10 mL / 0.33 Fl. Oz.

INGREDIENTS AND APPEARANCE

BB TINTED TREATMENT 12-HOUR PRIMER BROAD SPECTRUM SPF 30 SUNSCREEN   FAIR
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-324
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	45.5 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	35 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ISODODECANE (UNII: A8289P68Y2)
MICA (UNII: V8A1AW0880)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
BENZIMIDAZOLE (UNII: E24GX49LD8)
DIAMOND (UNII: 6GRV67N0U2)
STEARIC ACID (UNII: 4ELV7Z65AP)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
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: 51060-324-01	1 in 1 CARTON	09/01/2012
1		10 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/01/2012

BB TINTED TREATMENT 12-HOUR PRIMER BROAD SPECTRUM SPF 30 SUNSCREEN   LIGHT
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-325
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	45.5 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	35 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
MICA (UNII: V8A1AW0880)
ISODODECANE (UNII: A8289P68Y2)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
BENZIMIDAZOLE (UNII: E24GX49LD8)
DIAMOND (UNII: 6GRV67N0U2)
STEARIC ACID (UNII: 4ELV7Z65AP)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
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: 51060-325-01	1 in 1 CARTON	09/01/2012
1		10 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/01/2012

BB TINTED TREATMENT 12-HOUR PRIMER BROAD SPECTRUM SPF 30 SUNSCREEN   MEDIUM
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-326
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	45.5 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	35 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ISODODECANE (UNII: A8289P68Y2)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
MICA (UNII: V8A1AW0880)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
STEARIC ACID (UNII: 4ELV7Z65AP)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
DIAMOND (UNII: 6GRV67N0U2)
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: 51060-326-01	1 in 1 CARTON	09/01/2012
1		10 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/01/2012

BB TINTED TREATMENT 12-HOUR PRIMER BROAD SPECTRUM SPF 30 SUNSCREEN   TAN
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-327
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	45.5 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	35 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ISODODECANE (UNII: A8289P68Y2)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
STEARIC ACID (UNII: 4ELV7Z65AP)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
DIAMOND (UNII: 6GRV67N0U2)
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: 51060-327-01	1 in 1 CARTON	09/01/2012
1		10 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/01/2012

BB TINTED TREATMENT 12-HOUR PRIMER BROAD SPECTRUM SPF 30 SUNSCREEN   DEEP
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-328
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	45.5 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	35 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ISODODECANE (UNII: A8289P68Y2)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
DIAMOND (UNII: 6GRV67N0U2)
STEARIC ACID (UNII: 4ELV7Z65AP)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
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: 51060-328-01	1 in 1 CARTON	09/01/2012
1		10 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/01/2012

BB TINTED TREATMENT 12-HOUR PRIMER BROAD SPECTRUM SPF 30 SUNSCREEN   RICH
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-329
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	45.5 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	35 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ISODODECANE (UNII: A8289P68Y2)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
STEARIC ACID (UNII: 4ELV7Z65AP)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
ALUMINUM OXIDE (UNII: LMI26O6933)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
DIAMOND (UNII: 6GRV67N0U2)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-329-01	1 in 1 CARTON	09/01/2012
1		10 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/01/2012

Labeler - Tarte, Inc. (027905186)