TOTAL EYE 3-IN-1 RENEWAL THERAPY SPF 35- titanium dioxide and zinc oxide liquid

Total Eye 3-In-1 Renewal Therapy SPF 35 by

Drug Labeling and Warnings

Total Eye 3-In-1 Renewal Therapy SPF 35 by is a Otc medication manufactured, distributed, or labeled by Colorescience. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Titanium Dioxide 7.9%	Sunscreen
Zinc Oxide 6.7%	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. Works best on moisturized skin.
• Reapply at least every 2 hours
• Use a water resistant sunscreen if swimming or sweating
• 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.

Inactive Ingredients

Aqua/Water, Hydrogenated Polyisobutene, Cyclopentasiloxane, Caprylic/Capric Triglyceride, Lauryl Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Glycerin, Panthenol, Mica, Dimethicone Crosspolymer, Albizia Julibrissin Bark Extract, Sea Water, Sorbitol, Jojoba Esters, Sodium Hyaluronate, Palmitoyl Tripeptide-5, Tremella Fuciformis Sporocarp Extract, Hydrolyzed Algin, Ascophyllum Nodosum Extract, Betaine, Dunaliella Salina Extract, Asparagopsis Armata Extract, Sucrose, Darutoside, Pantolactone, Tocopherol, Sodium Chloride, Dimethicone/Vinyl Dimethicone Crosspolymer, Silica, Polyhydroxystearic Acid, Glyceryl Behenate/Eicosadioate, Dimethicone, Lauroyl Lysine, Dimethiconol, Ethylhexylglycerin, Triethoxycaprylylsilane, Alumina, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate, Citric Acid, Iron Oxides (CI 77491, CI 77492, CI 77499)

Other Information

Protect this product from excessive heat and direct sun.

Questions or comments?

Call toll free 866.426.5673

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Dist. in USA by colorescience®
Carlsbad, CA 92011

PRINCIPAL DISPLAY PANEL - 7 mL Tube Carton

colorescience®

TOTAL
EYE™

3-IN-1 RENEWAL
THERAPY

Corrects dark circles

Brightens and depuffs

Smooths fine lines
and wrinkles

35
Broad Spectrum
SPF 35 Sunscreen
PA+++

0.23 fl. oz. / 7 mL

OPEN

INGREDIENTS AND APPEARANCE

TOTAL EYE 3-IN-1 RENEWAL THERAPY SPF 35 
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68078-024
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	79 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	67 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
Glycerin (UNII: PDC6A3C0OX)
Panthenol (UNII: WV9CM0O67Z)
Mica (UNII: V8A1AW0880)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
ALBIZIA JULIBRISSIN BARK (UNII: 0J9G6W44DV)
Sorbitol (UNII: 506T60A25R)
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
Palmitoyl Tripeptide-5 (UNII: 2A3916MQHO)
ASCOPHYLLUM NODOSUM (UNII: 168S4EO8YJ)
Betaine (UNII: 3SCV180C9W)
DUNALIELLA SALINA (UNII: F4O1DKI9A6)
ASPARAGOPSIS ARMATA (UNII: 2936KN6I1G)
Sucrose (UNII: C151H8M554)
Darutoside (UNII: EG8ODI0780)
PANTOLACTONE, (+/-)- (UNII: IID733HD2M)
Tocopherol (UNII: R0ZB2556P8)
Sodium Chloride (UNII: 451W47IQ8X)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)
Glyceryl Behenate/Eicosadioate (UNII: 73CJJ317SR)
Dimethicone (UNII: 92RU3N3Y1O)
Lauroyl Lysine (UNII: 113171Q70B)
Ethylhexylglycerin (UNII: 147D247K3P)
Triethoxycaprylylsilane (UNII: LDC331P08E)
ALUMINUM OXIDE (UNII: LMI26O6933)
Phenoxyethanol (UNII: HIE492ZZ3T)
Potassium Sorbate (UNII: 1VPU26JZZ4)
Sodium Benzoate (UNII: OJ245FE5EU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68078-024-01	1 in 1 CARTON	01/19/2018
1		7 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 68078-024-02	0.5 mL in 1 PACKET; Type 0: Not a Combination Product	01/19/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/19/2018

Labeler - Colorescience (128731929)