TOTAL EYE CARE  SPF 15- titanium dioxide lotion 
Dermalogica

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Total Eye Care
SPF 15

Drug Facts

Active ingredient

Titanium Dioxide (4.5%)

Purpose

Sunscreen

Uses

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

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®

Principal Display Panel - 15 mL Tube Carton
TOTAL EYE CARE   SPF 15
titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68479-360
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide45 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorPINKScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68479-360-021 in 1 CARTON
115 mL in 1 TUBE
2NDC:68479-360-014 mL in 1 TUBE
3NDC:68479-360-002 mL in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/29/2012
Labeler - Dermalogica (177698560)
Establishment
NameAddressID/FEIBusiness Operations
PakLab177711082MANUFACTURE(68479-360)
Establishment
NameAddressID/FEIBusiness Operations
Diamond Wipes161104729MANUFACTURE(68479-360)

Revised: 12/2013
Document Id: 8296bbf4-b9ea-4037-ab3c-9a9458575188
Set id: 66f53ef8-03e7-48da-9365-02832e08b08f
Version: 1
Effective Time: 20131223
 
Dermalogica