TITANIUM DIOXIDE- sunscreen cream

Titanium Dioxide by

Drug Labeling and Warnings

Titanium Dioxide by is a Otc medication manufactured, distributed, or labeled by Tecnocosmesi S.p.A. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Titanium Dioxide 9.90%

Purpose

Suncreen

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

Water/Aqua/Eau, dimethicone, octyldodecyl stearoyl stearate, glycerin, phenyl trimethicone, magnesium sulfate, octyldodecanol, hydrogenated castor oil, cetyl PEG/PPG-10/1 dimethicone, polyglyceryl-3 diisostearate, cetyl dimethicone, disteardimonium hectorite, tremella fuciformis (mushroom) extract, aloe barbadensis leaf juice powder, persea gratissima (avocado) oil, opuntia ficus-indica stem extract, squalane, sodium hyaluronate, glycyrrhiza glabra (licorice) root extract, caprylyl glycol, stearic acid, alumina, potassium sorbate, sodium dehydroacetate, trimethylsiloxysilicate, sodium benzoate, xanthan gum, tocopherol, ethylhexyl palmitate, methicone, butylene glycol, 1,2-hexanediol, trihydroxystearin, sodium hyaluronate, disodium phosphate, ascorbyl palmitate, glucomannan, titanium dioxide (CI 77891), iron oxides (CI 77491, CI 77492, CI 77499), TE111FL000831.

Principal Display Panel

tarte

high performance naturals

shape tape

cloud coverage

Broad Spectrum

SPF 15 Sunscreen

INGREDIENTS AND APPEARANCE

TITANIUM DIOXIDE 
sunscreen cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66888-351
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	99 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
WATER (UNII: 059QF0KO0R)
AVOCADO OIL (UNII: 6VNO72PFC1)
OPUNTIA FICUS-INDICA STEM (UNII: MUD8892KHL)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
KONJAC MANNAN (UNII: 36W3E5TAMG)
TOCOPHEROL (UNII: R0ZB2556P8)
DIMETHICONE (UNII: 92RU3N3Y1O)
OCTYLDODECANOL (UNII: 461N1O614Y)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TREMELLA FUCIFORMIS WHOLE (UNII: 4938BNS0GU)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
ALUMINUM OXIDE (UNII: LMI26O6933)
DIMETHICONOL/TRIMETHYLSILOXYSILICATE CROSSPOLYMER (35/65 W/W; 10000000 PA.S) (UNII: TEU31AO9BN)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER (UNII: 788QAG3W8A)
CETYL DIMETHICONE/BIS-VINYLDIMETHICONE CROSSPOLYMER (UNII: AE7QA6TW0Q)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
FERRIC OXIDE RED (UNII: 1K09F3G675)
SODIUM BENZOATE (UNII: OJ245FE5EU)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
SQUALANE (UNII: GW89575KF9)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
STEARIC ACID (UNII: 4ELV7Z65AP)
XANTHAN GUM (UNII: TTV12P4NEE)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C)
GLYCERIN (UNII: PDC6A3C0OX)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
METHICONE (20 CST) (UNII: 6777U11MKT)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66888-351-01	1 in 1 CARTON	09/24/2021
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 Drug	M020	09/24/2021

Labeler - Tecnocosmesi S.p.A (435445218)