SEA SET AND PROTECT MINERAL SUNSCREEN BROAD SPECTRUM SPF 30 TRANSLUCENT- titanium dioxide and zinc oxide powder SEA SET AND PROTECT MINERAL SUNSCREEN BROAD SPECTRUM SPF 30 TRANSLUCENT DEEP- titanium dioxide and zinc oxide powder

SEA set and protect mineral sunscreen Broad Spectrum SPF 30 by

Drug Labeling and Warnings

SEA set and protect mineral sunscreen Broad Spectrum SPF 30 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 8.6%	Sunscreen
Zinc Oxide 10.0%	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

Polymethylsilsesquioxane, silica, jojoba esters, caprylyl glycol, alumina, sodium dehydroacetate, phenoxyethanol, vanillin, caprylic/capric triglyceride, hexylene glycol, vanilla planifolia fruit extract, aluminum dimyristate, triethoxycaprylylsilane, disodium stearoyl glutamate, mica, iron oxides. OX100FW000041.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 8 g Tube Carton - translucent

tarte™

SEA

set & protect
mineral powder
sunscreen
Broad Spectrum SPF 30

net wt 8 g / 0.28 Oz.

PRINCIPAL DISPLAY PANEL - 8 g Tube Carton - translucent deep

tarte™

SEA

set & protect
mineral powder sunscreen
Broad Spectrum SPF 30

net wt 8 g / 0.28 Oz.

INGREDIENTS AND APPEARANCE

SEA SET AND PROTECT MINERAL SUNSCREEN BROAD SPECTRUM SPF 30   TRANSLUCENT
titanium dioxide and zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-236
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	86 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALUMINUM OXIDE (UNII: LMI26O6933)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
VANILLIN (UNII: CHI530446X)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
VANILLA (UNII: Q74T35078H)
ALUMINUM DIMYRISTATE (UNII: J2KA067N9O)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-236-01	1 in 1 CARTON	03/05/2020
1		8 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	03/05/2020

SEA SET AND PROTECT MINERAL SUNSCREEN BROAD SPECTRUM SPF 30   TRANSLUCENT DEEP
titanium dioxide and zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51060-237
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	86 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)
ALUMINUM OXIDE (UNII: LMI26O6933)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
VANILLIN (UNII: CHI530446X)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
VANILLA (UNII: Q74T35078H)
MICA (UNII: V8A1AW0880)
ALUMINUM DIMYRISTATE (UNII: J2KA067N9O)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51060-237-01	1 in 1 CARTON	03/05/2020
1		8 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	03/05/2020

Labeler - Tarte, Inc. (027905186)