TOTAL EYE CARE SPF 15- titanium dioxide lotion

Total Eye Care by

Drug Labeling and Warnings

Total Eye Care by is a Otc medication manufactured, distributed, or labeled by Dermalogica, Inc., Thibiant, Diamond Wipes. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Titanium Dioxide (5.0%)

Purpose

Sunscreen

Use

• Helps prevent sunburn.
• If used as directed with other sun protection measures (see Directions), helps decrease 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 evenly 15 minutes before sun exposure.
• Reapply at least every 2 hours.
• Use a water resistant sunscreen if swimming or sweating.
• Sun Protection Measures.
  Spending time in the sun increases your risk of skin cancer and early skin aging. To help decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and take other sun protection measures including:
  • - Limit time in the sun, especially from 10 a.m. – 2 p.m.
  • - Wear long-sleeve shirts, pants, hats and sunglasses.
• Children under 6 months: ask a doctor.

Other information

• Protect this product from excessive heat and direct sun.

Inactive ingredients

Water/Aqua/Eau, C12-15 Alkyl Ethylhexanoate, Glycerin, Butylene Glycol, Silica, Thermus Thermophillus Ferment, Lactic Acid, Potassium Cetyl Phosphate, Cetearyl Alcohol, Betaine, Glyceryl Stearate SE, Magnesium Aluminum Silicate, PEG-100 Stearate, Saccharomyces Cerevisiae Extract, Rhodiola Rosea Root Extract, Citrus Aurantium Amara (Bitter Orange) Flower Extract, Bisabolol, Allantoin, Sodium PCA, Tocopheryl Acetate, Xanthan Gum, Dimethicone, Triethoxycaprylylsilane, Tocopherol, Ceteareth-20, Sodium Hydroxide, Silica Dimethyl Silylate, Tetrasodium Glutamate Diacetate, Salicylic Acid, Potassium Sorbate, Ethylhexylglycerin, Benzyl Alcohol, Linalool, Limonene, Mica, Phenoxyethanol, Iron Oxides (CI 77492, CI 77491).

Questions or comments?

Call toll free 1-800-831-5150 in the US

PRINCIPAL DISPLAY PANEL - 15 mL Tube Carton

total
eye
care

spf
15
broad
spectrum

dermalogica®

0.5 US FL OZ
15 mL e

INGREDIENTS AND APPEARANCE

TOTAL EYE CARE  SPF 15
titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68479-608
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

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
C12-15 Alkyl Ethylhexanoate (UNII: GQJ580CH83)
Glycerin (UNII: PDC6A3C0OX)
Butylene Glycol (UNII: 3XUS85K0RA)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
THERMUS THERMOPHILUS LYSATE (UNII: 775R692494)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
Betaine (UNII: 3SCV180C9W)
Glyceryl Stearate SE (UNII: FCZ5MH785I)
Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)
PEG-100 Stearate (UNII: YD01N1999R)
SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)
SEDUM ROSEUM ROOT (UNII: 3S5ITS5ULN)
LEVOMENOL (UNII: 24WE03BX2T)
Allantoin (UNII: 344S277G0Z)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
Xanthan Gum (UNII: TTV12P4NEE)
Dimethicone (UNII: 92RU3N3Y1O)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Tocopherol (UNII: R0ZB2556P8)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
Sodium Hydroxide (UNII: 55X04QC32I)
Silica Dimethyl Silylate (UNII: EU2PSP0G0W)
Tetrasodium Glutamate Diacetate (UNII: 5EHL50I4MY)
Salicylic Acid (UNII: O414PZ4LPZ)
Potassium Sorbate (UNII: 1VPU26JZZ4)
Ethylhexylglycerin (UNII: 147D247K3P)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
Mica (UNII: V8A1AW0880)
Phenoxyethanol (UNII: HIE492ZZ3T)
FERROUS OXIDE (UNII: G7036X8B5H)

Product Characteristics
Color	PINK	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68479-608-02	1 in 1 CARTON	03/01/2018
1		15 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 68479-608-01	4 mL in 1 TUBE; Type 0: Not a Combination Product	03/01/2018
3	NDC: 68479-608-00	2 mL in 1 POUCH; Type 0: Not a Combination Product	03/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/01/2018

Labeler - Dermalogica, Inc. (177698560)

Establishment
Name	Address	ID/FEI	Business Operations
Thibiant		083913913	MANUFACTURE(68479-608)

Establishment
Name	Address	ID/FEI	Business Operations
Diamond Wipes		161104729	MANUFACTURE(68479-608)