EVEN TONE MINERAL SUNSCREEN BROAD SPECTRUM SPF 40 LIGHT - MEDIUM- titanium dioxide and zinc oxide lotion

Even Tone Mineral Sunscreen Broad Spectrum SPF 40 Light - Medium by

Drug Labeling and Warnings

Even Tone Mineral Sunscreen Broad Spectrum SPF 40 Light - Medium by is a Otc medication manufactured, distributed, or labeled by SENTÉ, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Titanium Dioxide 4.25%	Sunscreen
Zinc Oxide 7.80%	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

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply liberally 15 minutes before sun exposure
• Reapply:
  • After 40 minutes of swimming or sweating
  • Immediately after towel drying
  • At least every 2 hours

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.
• Children under 6 months of age: Ask a doctor

Inactive ingredients

Water (Aqua), Dimethicone, Cyclopentasiloxane, PEG-10 Dimethicone, Pentylene Glycol, Hexyl Laurate, Polyglyceryl-4 Isostearate, Sodium Chloride, Heparan Sulfate, Glycerin, Fructose, Tocopheryl Acetate, Tocopherol, Withania Somnifera Root Extract, Iron Oxides (C.I. 77491, C.I. 77492, C.I. 77499), Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Dimethicone/Polyglyceryin-3 Crosspolymer, Stearic Acid, Alumina, Sodium Citrate, Dimethicone/Vinyl Dimethicone Crosspolymer, PEG/PPG-18/18 Dimethicone, Triethoxycaprylylsilane, Phenoxyethanol, Ethylhexylglycerin.

Other information

Protect the product in this container from excessive heat and direct sun

Questions or comments?

(800) 205-6774

www.sentelabs.com

PRINCIPAL DISPLAY PANEL - 50 mL Tube Label

Senté®

Even Tone
Mineral Sunscreen

Broad Spectrum Lotion
SPF 40

LIGHT - MEDIUM
Water Resistant (40 minutes)

HSA

PROTECT

50 mL / 1.7 FL OZ

INGREDIENTS AND APPEARANCE

EVEN TONE MINERAL SUNSCREEN BROAD SPECTRUM SPF 40 LIGHT - MEDIUM 
titanium dioxide and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71398-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	47.43 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	87.048 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Dimethicone (UNII: 92RU3N3Y1O)
Cyclomethicone 5 (UNII: 0THT5PCI0R)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
Pentylene Glycol (UNII: 50C1307PZG)
Hexyl Laurate (UNII: 4CG9F9W01Q)
Polyglyceryl-4 Isostearate (UNII: 820DPX33S7)
Sodium Chloride (UNII: 451W47IQ8X)
HEPARAN SULFATE (PORCINE 5500 MW) (UNII: 47959853R5)
Glycerin (UNII: PDC6A3C0OX)
Fructose (UNII: 6YSS42VSEV)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
Tocopherol (UNII: R0ZB2556P8)
WITHANIA SOMNIFERA ROOT (UNII: V038D626IF)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
Stearic Acid (UNII: 4ELV7Z65AP)
ALUMINUM OXIDE (UNII: LMI26O6933)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
Phenoxyethanol (UNII: HIE492ZZ3T)
Ethylhexylglycerin (UNII: 147D247K3P)

Product Characteristics
Color	BROWN	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71398-013-01	1 in 1 CARTON	06/10/2022
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 71398-013-02	1 in 1 CARTON	06/10/2022
2		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 drug	M020	06/10/2022

Labeler - SENTÉ, Inc. (079245446)