TOTAL EYE CARE SPF 15- titanium dioxide lotion 
Dermalogica, Inc.

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.

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Total Eye Care

Drug Facts

Active ingredient

Titanium Dioxide (5.0%)

Purpose

Sunscreen

Use

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

Other information

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

PRINCIPAL DISPLAY PANEL - 15 mL Tube Carton
TOTAL EYE CARE  SPF 15
titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68479-608
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorPINKScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68479-608-021 in 1 CARTON03/01/2018
115 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:68479-608-014 mL in 1 TUBE; Type 0: Not a Combination Product03/01/2018
3NDC:68479-608-002 mL in 1 POUCH; Type 0: Not a Combination Product03/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/01/2018
Labeler - Dermalogica, Inc. (177698560)
Establishment
NameAddressID/FEIBusiness Operations
Thibiant083913913MANUFACTURE(68479-608)
Establishment
NameAddressID/FEIBusiness Operations
Diamond Wipes161104729MANUFACTURE(68479-608)

Revised: 12/2017
Document Id: d67c5464-4878-40f1-af9a-2eb39649fc84
Set id: 8de23745-a2c5-4e82-a73a-dd3fcc1799bd
Version: 1
Effective Time: 20171229
 
Dermalogica, Inc.