TARTEGUARD 20 TINTED MOISTURIZER LIGHT- titanium dioxide and zinc oxide liquid TARTEGUARD 20 TINTED MOISTURIZER LIGHT-MEDIUM- titanium dioxide and zinc oxide liquid TARTEGUARD 20 TINTED MOISTURIZER MEDIUM- titanium dioxide and zinc oxide liquid

Tarteguard 20 Tinted Moisturizer by

Drug Labeling and Warnings

Tarteguard 20 Tinted Moisturizer 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 5%	Sunscreen
Zinc Oxide 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

• 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

Water, cyclopentasiloxane, PEG/PPG-18/18 dimethicone, octyldodecyl neopentanoate, glycerin, dimethicone, aluminum hydroxide, stearic acid, phenoxyethanol, mica, boron nitride, sodium dehydroacetate, caprylyl glycol, sodium chloride, phytantriol, kaolin, magnesium ascorbyl phosphate, palmitic acid, dextrin palmitate, sodium hyaluronate, hexylene glycol, retinyl palmitate, tocopheryl acetate, tocopherol, tetrahexyldecyl ascorbate, methicone, butylene glycol, triethoxycaprylylsilane, calcium sodium phosphosilicate, saccharum officinarum (sugar cane) extract, pyrus malus (apple) fruit extract, citrus limon (lemon) fruit extract, citrus aurantium dulcis (orange) fruit extract, camellia oleifera leaf extract, panax ginseng root extract, ginkgo biloba leaf extract, anthemis nobilis flower extract, iron oxides.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton - light

tarte
high-performance naturals™

TARTEGUARD
20

tinted moisturizer
Broad Spectrum
SPF 20 Sunscreen

net 50 mL / 1.7 Fl. Oz.

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton - light-medium

tarte
high-performance naturals™

TARTEGUARD
20

tinted moisturizer
Broad Spectrum
SPF 20 Sunscreen

net 50 mL / 1.7 Fl. Oz.

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton - medium

tarte
high-performance naturals™

TARTEGUARD
20

tinted moisturizer
Broad Spectrum
SPF 20 Sunscreen

net 50 mL / 1.7 Fl. Oz.

INGREDIENTS AND APPEARANCE

TARTEGUARD 20 TINTED MOISTURIZER   LIGHT
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-114
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	50 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
cyclomethicone 5 (UNII: 0THT5PCI0R)
peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)
octyldodecyl neopentanoate (UNII: X8725R883T)
glycerin (UNII: PDC6A3C0OX)
dimethicone (UNII: 92RU3N3Y1O)
aluminum hydroxide (UNII: 5QB0T2IUN0)
stearic acid (UNII: 4ELV7Z65AP)
phenoxyethanol (UNII: HIE492ZZ3T)
mica (UNII: V8A1AW0880)
boron nitride (UNII: 2U4T60A6YD)
sodium dehydroacetate (UNII: 8W46YN971G)
caprylyl glycol (UNII: 00YIU5438U)
sodium chloride (UNII: 451W47IQ8X)
phytantriol (UNII: 8LVI07A72W)
kaolin (UNII: 24H4NWX5CO)
magnesium ascorbyl phosphate (UNII: 0R822556M5)
palmitic acid (UNII: 2V16EO95H1)
hyaluronate sodium (UNII: YSE9PPT4TH)
hexylene glycol (UNII: KEH0A3F75J)
vitamin A palmitate (UNII: 1D1K0N0VVC)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
tocopherol (UNII: R0ZB2556P8)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
methicone (20 cst) (UNII: 6777U11MKT)
butylene glycol (UNII: 3XUS85K0RA)
triethoxycaprylylsilane (UNII: LDC331P08E)
sugarcane (UNII: 81H2R5AOH3)
apple (UNII: B423VGH5S9)
lemon (UNII: 24RS0A988O)
orange (UNII: 5EVU04N5QU)
camellia oleifera leaf (UNII: 5077EL0C60)
asian ginseng (UNII: CUQ3A77YXI)
ginkgo (UNII: 19FUJ2C58T)
chamaemelum nobile flower (UNII: O2T154T6OG)
ferric oxide red (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-114-01	1 in 1 CARTON	04/01/2017
1		50 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	04/01/2017

TARTEGUARD 20 TINTED MOISTURIZER   LIGHT-MEDIUM
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-115
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	50 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
cyclomethicone 5 (UNII: 0THT5PCI0R)
peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)
octyldodecyl neopentanoate (UNII: X8725R883T)
glycerin (UNII: PDC6A3C0OX)
dimethicone (UNII: 92RU3N3Y1O)
aluminum hydroxide (UNII: 5QB0T2IUN0)
stearic acid (UNII: 4ELV7Z65AP)
phenoxyethanol (UNII: HIE492ZZ3T)
mica (UNII: V8A1AW0880)
boron nitride (UNII: 2U4T60A6YD)
sodium dehydroacetate (UNII: 8W46YN971G)
caprylyl glycol (UNII: 00YIU5438U)
sodium chloride (UNII: 451W47IQ8X)
phytantriol (UNII: 8LVI07A72W)
kaolin (UNII: 24H4NWX5CO)
magnesium ascorbyl phosphate (UNII: 0R822556M5)
palmitic acid (UNII: 2V16EO95H1)
hyaluronate sodium (UNII: YSE9PPT4TH)
hexylene glycol (UNII: KEH0A3F75J)
vitamin A palmitate (UNII: 1D1K0N0VVC)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
tocopherol (UNII: R0ZB2556P8)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
methicone (20 cst) (UNII: 6777U11MKT)
butylene glycol (UNII: 3XUS85K0RA)
triethoxycaprylylsilane (UNII: LDC331P08E)
sugarcane (UNII: 81H2R5AOH3)
apple (UNII: B423VGH5S9)
lemon (UNII: 24RS0A988O)
orange (UNII: 5EVU04N5QU)
camellia oleifera leaf (UNII: 5077EL0C60)
asian ginseng (UNII: CUQ3A77YXI)
ginkgo (UNII: 19FUJ2C58T)
chamaemelum nobile flower (UNII: O2T154T6OG)
ferric oxide red (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-115-01	1 in 1 CARTON	04/01/2017
1		50 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	04/01/2017

TARTEGUARD 20 TINTED MOISTURIZER   MEDIUM
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-116
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	50 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
cyclomethicone 5 (UNII: 0THT5PCI0R)
peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)
octyldodecyl neopentanoate (UNII: X8725R883T)
glycerin (UNII: PDC6A3C0OX)
dimethicone (UNII: 92RU3N3Y1O)
aluminum hydroxide (UNII: 5QB0T2IUN0)
stearic acid (UNII: 4ELV7Z65AP)
phenoxyethanol (UNII: HIE492ZZ3T)
mica (UNII: V8A1AW0880)
boron nitride (UNII: 2U4T60A6YD)
sodium dehydroacetate (UNII: 8W46YN971G)
caprylyl glycol (UNII: 00YIU5438U)
sodium chloride (UNII: 451W47IQ8X)
phytantriol (UNII: 8LVI07A72W)
kaolin (UNII: 24H4NWX5CO)
magnesium ascorbyl phosphate (UNII: 0R822556M5)
palmitic acid (UNII: 2V16EO95H1)
hyaluronate sodium (UNII: YSE9PPT4TH)
hexylene glycol (UNII: KEH0A3F75J)
vitamin A palmitate (UNII: 1D1K0N0VVC)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
tocopherol (UNII: R0ZB2556P8)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
methicone (20 cst) (UNII: 6777U11MKT)
butylene glycol (UNII: 3XUS85K0RA)
triethoxycaprylylsilane (UNII: LDC331P08E)
sugarcane (UNII: 81H2R5AOH3)
apple (UNII: B423VGH5S9)
lemon (UNII: 24RS0A988O)
orange (UNII: 5EVU04N5QU)
camellia oleifera leaf (UNII: 5077EL0C60)
asian ginseng (UNII: CUQ3A77YXI)
ginkgo (UNII: 19FUJ2C58T)
chamaemelum nobile flower (UNII: O2T154T6OG)
ferric oxide red (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-116-01	1 in 1 CARTON	04/01/2017
1		50 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	04/01/2017

Labeler - Tarte, Inc (027905186)