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

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 3.50%	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

• 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
• Optional: apply to all skin exposed to the sun
• 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, New Jersey 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. NY 10018.

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - Fair

tarte
high-performance naturals™

BB tinted treatment primer

Broad Spectrum
SPF 30 Sunscreen

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - Light

tarte
high-performance naturals™

BB tinted treatment primer

Broad Spectrum
SPF 30 Sunscreen

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - Medium

tarte
high-performance naturals™

BB tinted treatment primer

Broad Spectrum
SPF 30 Sunscreen

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - Tan-Deep

tarte
high-performance naturals™

BB tinted treatment primer

Broad Spectrum
SPF 30 Sunscreen

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - Tan

tarte
high-performance naturals™

BB tinted treatment 12-hour primer

Broad Spectrum
SPF 30 Sunscreen

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton - Medium-Tan

tarte
high-performance naturals™

BB tinted treatment primer

Broad Spectrum
SPF 30 Sunscreen

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-018
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)
hexyl laurate (UNII: 4CG9F9W01Q)
polyglyceryl-4 isostearate (UNII: 820DPX33S7)
stearic acid (UNII: 4ELV7Z65AP)
aluminum oxide (UNII: LMI26O6933)
triethoxycaprylylsilane (UNII: LDC331P08E)
dipalmitoyl hydroxyproline (UNII: E6AHA53N1H)
diamond (UNII: 6GRV67N0U2)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-018-01	1 in 1 CARTON	01/01/2014
1		30 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 cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-019
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)
hexyl laurate (UNII: 4CG9F9W01Q)
polyglyceryl-4 isostearate (UNII: 820DPX33S7)
stearic acid (UNII: 4ELV7Z65AP)
aluminum oxide (UNII: LMI26O6933)
triethoxycaprylylsilane (UNII: LDC331P08E)
dipalmitoyl hydroxyproline (UNII: E6AHA53N1H)
diamond (UNII: 6GRV67N0U2)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-019-01	1 in 1 CARTON	01/01/2014
1		30 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 cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-020
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)
hexyl laurate (UNII: 4CG9F9W01Q)
polyglyceryl-4 isostearate (UNII: 820DPX33S7)
stearic acid (UNII: 4ELV7Z65AP)
aluminum oxide (UNII: LMI26O6933)
triethoxycaprylylsilane (UNII: LDC331P08E)
dipalmitoyl hydroxyproline (UNII: E6AHA53N1H)
diamond (UNII: 6GRV67N0U2)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-020-01	1 in 1 CARTON	01/01/2014
1		30 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 DEEP
titanium dioxide and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-023
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)
hexyl laurate (UNII: 4CG9F9W01Q)
polyglyceryl-4 isostearate (UNII: 820DPX33S7)
stearic acid (UNII: 4ELV7Z65AP)
aluminum oxide (UNII: LMI26O6933)
triethoxycaprylylsilane (UNII: LDC331P08E)
dipalmitoyl hydroxyproline (UNII: E6AHA53N1H)
diamond (UNII: 6GRV67N0U2)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-023-01	1 in 1 CARTON	01/01/2014
1		30 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 cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-022
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)
hexyl laurate (UNII: 4CG9F9W01Q)
polyglyceryl-4 isostearate (UNII: 820DPX33S7)
stearic acid (UNII: 4ELV7Z65AP)
aluminum oxide (UNII: LMI26O6933)
triethoxycaprylylsilane (UNII: LDC331P08E)
dipalmitoyl hydroxyproline (UNII: E6AHA53N1H)
diamond (UNII: 6GRV67N0U2)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-022-01	1 in 1 CARTON	01/01/2014	12/31/2017
1		30 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	12/31/2017

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-021
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)
hexyl laurate (UNII: 4CG9F9W01Q)
polyglyceryl-4 isostearate (UNII: 820DPX33S7)
stearic acid (UNII: 4ELV7Z65AP)
aluminum oxide (UNII: LMI26O6933)
triethoxycaprylylsilane (UNII: LDC331P08E)
dipalmitoyl hydroxyproline (UNII: E6AHA53N1H)
diamond (UNII: 6GRV67N0U2)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-021-01	1 in 1 CARTON	01/01/2014
1		30 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	01/01/2014

Labeler - Tarte, Inc (027905186)