ULTRASENSITIVE TINT  SPF 30- 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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UltraSensitive Tint
SPF 30

Drug Facts

Active Ingredient

Titanium Dioxide 11.0%

Purpose

Sunscreen

Uses

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.

Do not use if seal is broken.

Directions

Inactive ingredients

Water/Aqua, Butylene Glycol, Cyclopentasiloxane, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Neopentyl Glycol Diethylhexanoate, Arachidyl Alcohol, PEG-10 Dimethicone, Dimethicone, Behenyl Alcohol, Leuconostoc/Radish Root Ferment Filtrate, Stearyl Dimethicone, Potassium Cetyl Phosphate, Camellia Oleifera Leaf Extract, Avena Sativa (Oat) Kernel Extract, Boerhavia Diffusa Root Extract, Melissa Officinalis Extract, Vitis Vinifera (Grape) Seed Extract, Citrus Medica Limonum (Lemon) Peel Extract, Centella Asiatica Extract, Echinacea Purpurea Extract, Zingiber Officinale (Ginger) Root Extract, Citrus Grandis (Grapefruit) Peel Oil, Lavandula Angustifolia (Lavender) Oil, Thymus Vulgaris (Thyme) Oil, Pelargonium Graveolens Oil, Aniba Rosaeodora (Rosewood) Wood Oil, Citrus Aurantium Dulcis (Orange) Oil, Bisabolol, Tocopherol, Lecithin, Panthenol, Sodium Lactate, Sodium PCA, Sorbitol, Proline, Pentylene Glycol, Hydroxyphenyl Propamidobenzoic Acid, Glycerin, Magnesium Ascorbyl Phosphate, Silica, Arachidyl Glucoside, Cetearyl Alcohol, Ceteareth-20, Sodium DNA, Ascorbyl Tetraisopalmitate, Neopentyl Glycol Diisostearate, Alumina, Methicone, Stearic Acid, Aluminum Hydroxide, Polyglyceryl-2 Dipolyhydroxy Stearate, Polyglyceryl-3 Diiostearate, Xanthan Gum, Magnesium Aluminum Silicate, Carbomer, Disodium EDTA, Sodium Benzoate, Potassium Sorbate, Sodium Hydroxide, Iron Oxides (77491, 77492, 77499).

Other information

Questions or comments

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PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton

dermalogica®

ultra
sensitive
tint

spf
30

broad
spectrum

NPN# 80031341

UltraCalming

1.7 US Fl. Oz.
50 mL e

Principal Display Panel - 50 mL Tube Carton
ULTRASENSITIVE TINT   SPF 30
titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68479-120
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide110 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Cyclomethicone 5 (UNII: 0THT5PCI0R)  
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
Neopentyl Glycol Diethylhexanoate (UNII: U68ZV6W62C)  
Arachidyl Alcohol (UNII: 1QR1QRA9BU)  
PEG-10 Dimethicone (600 CST) (UNII: 8PR7V1SVM0)  
Dimethicone (UNII: 92RU3N3Y1O)  
Docosanol (UNII: 9G1OE216XY)  
Leuconostoc/Radish Root Ferment Filtrate (UNII: D2QHA03458)  
Stearyl Dimethicone (400 MPA.S at 50C) (UNII: R327X197HY)  
Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)  
Camellia Oleifera Leaf (UNII: 5077EL0C60)  
Oat (UNII: Z6J799EAJK)  
Boerhavia Diffusa Root (UNII: KR0SR09KYL)  
Melissa Officinalis (UNII: YF70189L0N)  
Vitis Vinifera Seed (UNII: C34U15ICXA)  
Lemon Peel (UNII: 72O054U628)  
Centella Asiatica (UNII: 7M867G6T1U)  
Echinacea Purpurea (UNII: QI7G114Y98)  
Ginger (UNII: C5529G5JPQ)  
Citrus Maxima Fruit Rind Oil (UNII: 8U3877WD44)  
Lavender Oil (UNII: ZBP1YXW0H8)  
Thyme Oil (UNII: 2UK410MY6B)  
Geranium Oil, Algerian Type (UNII: 5Q1I94P4WG)  
Rosewood Oil (UNII: F2522O5L7B)  
Orange Oil (UNII: AKN3KSD11B)  
Levomenol (UNII: 24WE03BX2T)  
Tocopherol (UNII: R0ZB2556P8)  
Egg Phospholipids (UNII: 1Z74184RGV)  
Panthenol (UNII: WV9CM0O67Z)  
Sodium Lactate (UNII: TU7HW0W0QT)  
Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2)  
Sorbitol (UNII: 506T60A25R)  
Proline (UNII: 9DLQ4CIU6V)  
Pentylene Glycol (UNII: 50C1307PZG)  
Hydroxyphenyl Propamidobenzoic Acid (UNII: 25KRT26H77)  
Glycerin (UNII: PDC6A3C0OX)  
Magnesium Ascorbyl Phosphate (UNII: 0R822556M5)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Arachidyl Glucoside (UNII: 6JVW35JOOJ)  
Cetostearyl Alcohol (UNII: 2DMT128M1S)  
Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)  
Ascorbyl Tetraisopalmitate (UNII: 47143LT58A)  
Neopentyl Glycol Diisostearate (UNII: 4M6OQ34JWW)  
Aluminum Oxide (UNII: LMI26O6933)  
Methicone (20 CST) (UNII: 6777U11MKT)  
Stearic Acid (UNII: 4ELV7Z65AP)  
Aluminum Hydroxide (UNII: 5QB0T2IUN0)  
Polyglyceryl-2 Dipolyhydroxystearate (UNII: 9229XJ4V12)  
Polyglyceryl-3 Diisostearate (UNII: 46P231IQV8)  
Xanthan Gum (UNII: TTV12P4NEE)  
Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)  
Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked) (UNII: 4Q93RCW27E)  
Edetate Disodium (UNII: 7FLD91C86K)  
Sodium Benzoate (UNII: OJ245FE5EU)  
Potassium Sorbate (UNII: 1VPU26JZZ4)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Ferric Oxide Red (UNII: 1K09F3G675)  
Ferric Oxide Yellow (UNII: EX438O2MRT)  
Ferrosoferric Oxide (UNII: XM0M87F357)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68479-120-021 in 1 CARTON
150 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:68479-120-002 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35203/14/2012
Labeler - Dermalogica, Inc. (177698560)
Establishment
NameAddressID/FEIBusiness Operations
PakLab790530976MANUFACTURE(68479-120)
Establishment
NameAddressID/FEIBusiness Operations
Diamond Wipes161104729MANUFACTURE(68479-120)

Revised: 11/2015
Document Id: 03728265-8b8d-43da-87fc-9e48c7fc0f3b
Set id: 2defa4fa-ca65-4cd1-9ec8-0039360429f7
Version: 2
Effective Time: 20151118
 
Dermalogica, Inc.