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, PakLab, Diamond Wipes. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Titanium Dioxide (4.5%)

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), may decrease the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only

Do not use on broken or damaged skin.

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

If irritation develops, discontinue use.

Do not use on infants under 6 months old.

Stop use and ask a physician if too much skin irritation or sensitivity develops or increases.

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
• After cleansing in the morning, gently pat around the entire eye area, blending inward from the outer corner.

Inactive ingredients

Water (Aqua), C12-15 Alkyl Ethylhexanoate, Butylene Glycol, Glycerin, Silica, Lactic Acid, Cetearyl Alcohol, Potassium Cetyl Phosphate, Magnesium Aluminum Silicate, Glyceryl Stearate, PEG-100 Stearate, Citrus Aurantium Amara (Bitter Orange) Flower Extract, Spiraea Ulmaria Flower Extract, Centella Asiatica Extract, Taurine, Leucine, Valine, Tyrosine, Arginine, Lysine, Sodium PCA, Tocopheryl Acetate, Bisabolol, Lauric Acid, Aluminum Hydroxide, Allantoin, Ceteareth-20, Xanthan Gum, Sodium Hydroxide, Propylene Glycol, Disodium EDTA, Ethylhexylglycerin, Phenoxyethanol, Talc, Iron Oxides (CI 77492, CI 77491), Mica (CI 77019).

Questions?

1-800-831-5150 in USA

PRINCIPAL DISPLAY PANEL - 15 mL Tube Carton

total
eye
care

spf
15
broad
spectrum

NPN #80011194
0.5 US Fl. Oz.
15 mL e

dermalogica®

INGREDIENTS AND APPEARANCE

TOTAL EYE CARE   SPF 15
titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68479-360
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	45 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Butylene Glycol (UNII: 3XUS85K0RA)
Glycerin (UNII: PDC6A3C0OX)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Lactic Acid (UNII: 33X04XA5AT)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)
Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)
Glyceryl Monostearate (UNII: 230OU9XXE4)
PEG-100 Stearate (UNII: YD01N1999R)
Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)
Citrus Aurantium Flower (UNII: O730ZX2Z83)
Phenoxyethanol (UNII: HIE492ZZ3T)
Propylene Glycol (UNII: 6DC9Q167V3)
Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2)
Filipendula Ulmaria Flower (UNII: 06L18L32G6)
Centella Asiatica (UNII: 7M867G6T1U)
Sodium Hydroxide (UNII: 55X04QC32I)
Aluminum Hydroxide (UNII: 5QB0T2IUN0)
Lysine (UNII: K3Z4F929H6)
Xanthan Gum (UNII: TTV12P4NEE)
Levomenol (UNII: 24WE03BX2T)
Arginine (UNII: 94ZLA3W45F)
Lauric Acid (UNII: 1160N9NU9U)
Edetate Disodium (UNII: 7FLD91C86K)
Taurine (UNII: 1EQV5MLY3D)
Tyrosine (UNII: 42HK56048U)
Ethylhexylglycerin (UNII: 147D247K3P)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Allantoin (UNII: 344S277G0Z)
Leucine (UNII: GMW67QNF9C)
Valine (UNII: HG18B9YRS7)
Talc (UNII: 7SEV7J4R1U)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
BARIUM CARBONATE (UNII: 6P669D8HQ8)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Product Characteristics
Color	PINK	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68479-360-02	1 in 1 CARTON
1		15 mL in 1 TUBE
2	NDC: 68479-360-01	4 mL in 1 TUBE
3	NDC: 68479-360-00	2 mL in 1 POUCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/29/2012

Labeler - Dermalogica (177698560)

Establishment
Name	Address	ID/FEI	Business Operations
PakLab		177711082	MANUFACTURE(68479-360)

Establishment
Name	Address	ID/FEI	Business Operations
Diamond Wipes		161104729	MANUFACTURE(68479-360)