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
Tarte, 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.

----------

BB Tinted Treatment 12-hour Primer Broad Spectrum SPF 30 Sunscreen

Drug Facts

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.

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 - Fair

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 - Light

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 - Medium

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-Deep

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 - Tan

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

tarte
high-performance naturals™

BB tinted treatment primer

Broad Spectrum
SPF 30 Sunscreen

Principal Display Panel - 30 mL Tube Carton - Medium-Tan

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51060-018-01	1 in 1 CARTON	01/01/2014	02/17/2021
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	09/01/2012	02/17/2021

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51060-019-01	1 in 1 CARTON	01/01/2014	02/17/2021
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	09/01/2012	02/17/2021

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51060-020-01	1 in 1 CARTON	01/01/2014	02/17/2021
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	09/01/2012	02/17/2021

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51060-023-01	1 in 1 CARTON	01/01/2014	02/17/2021
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	09/01/2012	02/17/2021

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	09/01/2012	02/17/2021

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51060-021-01	1 in 1 CARTON	01/01/2014	02/17/2021
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	01/01/2014	02/17/2021

Labeler - Tarte, Inc (027905186)

Revised: 2/2021

Document Id: 94ffe32e-62e8-445d-b102-d57706cac4c4

Set id: 7ae3c9c6-254e-4fad-974e-3e2ff295b19f

Version: 3

Effective Time: 20210218

Tarte, Inc