ULTRA SENSITIVE FACEBLOCK SPF 25- titanium dioxide lotion 
Gordon Laboratories, 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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dermalogica®
ultra
sensitive
faceblock

active ingredient

Titanium Dioxide (7.8%).

warnings

For external use only, not to be swallowed. Avoid contact with eyes. If contact occurs, flush thoroughly with water. Apply prior to sun exposure.

Discontinue use if skin irritation develops or increases. If irritation persists, consult a health care practitioner.

Do not use on infants under 6 months old.

other ingredients

Water (Aqua), Octyldodecyl Neopentanoate, Isononyl Isononanoate, Butylene Glycol, Neopentyl Glycol Diethylhexanoate, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Alcohol, Potassium Cetyl Phosphate, Stearic Acid, Neopentyl Glycol Diisostearate, Melissa Officinalis (Balm Mint) Leaf Extract, Camellia Oleifera (Green Tea) Leaf Extract, Echinacea Purpurea (Coneflower) Extract, Vitis Vinifera (Grape) Seed Extract, Citrus Medica Limonum (Lemon) Peel Extract, Centella Asiatica (Hydrocotyl) Extract, Proline, Lecithin, Magnesium Ascorbyl Phosphate, Panthenol, Retinyl Palmitate, Tocopherol, Citrus Grandis (Grapefruit) Peel Oil, Citrus Aurantium Dulcis (Orange) Oil, Aniba Rosaeodora (Rosewood) Wood Oil, Geranium Maculatum Oil, Lavendula Angustifolia (Lavender) Oil, Thymus Vulgaris (Thyme) Oil, Aluminum Hydroxide, Disodium EDTA, Xanthan Gum, Propylparaben, Linalool, Stearyl Dimethicone, Ceteareth-20, Polyglyceryl-6 Polyricinoleate, Sodium PCA, Sodium Lactate, Sorbitol, Magnesium Aluminum Silicate, Diazolidinyl Urea, Methylparaben, Talc, Limonene, Geraniol, Citronellol, Iron Oxides (CI 77491, CI 77492, CI 77499).

Dermalogica, Dist.
Los Angeles, CA 90009 USA
1-800-831-5150

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

dermalogica®

ultra
sensitive
faceblock

spf 25

NPN# 80012093
AUST L 78910

1.7 FL OZ / 50 ml e

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton
ULTRA SENSITIVE FACEBLOCK SPF 25 
titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21839-011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide4000 mg  in 50 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Octyldodecyl Neopentanoate (UNII: X8725R883T)  
Isononyl Isononanoate (UNII: S4V5BS6GCX)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Neopentyl Glycol Diethylhexanoate (UNII: U68ZV6W62C)  
Glyceryl Monostearate (UNII: 230OU9XXE4)  
PEG-100 Stearate (UNII: YD01N1999R)  
Cetostearyl Alcohol (UNII: 2DMT128M1S)  
Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)  
Stearic Acid (UNII: 4ELV7Z65AP)  
Neopentyl Glycol Disostearate (UNII: 4M6OQ34JWW)  
Melissa Officinalis Leaf (UNII: 50D2ZE9219)  
Camellia Oleifera Leaf (UNII: 5077EL0C60)  
Echinacea Purpurea (UNII: QI7G114Y98)  
Vitis Vinifera Seed (UNII: C34U15ICXA)  
Lemon Peel (UNII: 72O054U628)  
Centella Asiatica (UNII: 7M867G6T1U)  
Proline (UNII: 9DLQ4CIU6V)  
Magnesium Ascorbyl Phosphate (UNII: 0R822556M5)  
Panthenol (UNII: WV9CM0O67Z)  
Vitamin A Palmitate (UNII: 1D1K0N0VVC)  
Tocopherol (UNII: R0ZB2556P8)  
Citrus Maxima Fruit Rind Oil (UNII: 8U3877WD44)  
Rosewood Oil (UNII: F2522O5L7B)  
Lavender Oil (UNII: ZBP1YXW0H8)  
Thyme Oil (UNII: 2UK410MY6B)  
Aluminum Hydroxide (UNII: 5QB0T2IUN0)  
Edetate Disodium (UNII: 7FLD91C86K)  
Xanthan Gum (UNII: TTV12P4NEE)  
Propylparaben (UNII: Z8IX2SC1OH)  
Linalool, (+/-)- (UNII: D81QY6I88E)  
Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)  
Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2)  
Sodium Lactate (UNII: TU7HW0W0QT)  
Sorbitol (UNII: 506T60A25R)  
Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)  
Diazolidinyl Urea (UNII: H5RIZ3MPW4)  
Methylparaben (UNII: A2I8C7HI9T)  
Talc (UNII: 7SEV7J4R1U)  
Geraniol (UNII: L837108USY)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Product Characteristics
ColorBROWN (Light Brown) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21839-011-501 in 1 BOX
150 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35209/01/2009
Labeler - Gordon Laboratories, Inc (008328619)

Revised: 8/2011
Document Id: 377bd4d5-77fd-4361-903f-b974c33aa90b
Set id: 656fdb15-236b-4db3-ac6d-13f42fbddcc8
Version: 1
Effective Time: 20110803
 
Gordon Laboratories, Inc