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Ultra Sensitive Faceblock SPF 25

Dosage form: lotion
Ingredients: Titanium Dioxide 4000mg in 50mL
Labeler: Gordon Laboratories, Inc
NDC Code: 21839-011

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.

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

ULTRA SENSITIVE FACEBLOCK SPF 25 
titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21839-011
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (Titanium Dioxide) Titanium Dioxide4000 mg  in 50 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Octyldodecyl Neopentanoate 
Isononyl Isononanoate 
Butylene Glycol 
Neopentyl Glycol Diethylhexanoate 
Glyceryl Monostearate 
PEG-100 Stearate 
Cetostearyl Alcohol 
Potassium Cetyl Phosphate 
Stearic Acid 
Neopentyl Glycol Disostearate 
Melissa Officinalis Leaf 
Camellia Oleifera Leaf 
Echinacea Purpurea 
Vitis Vinifera Seed 
Lemon Peel 
Centella Asiatica 
Proline 
Magnesium Ascorbyl Phosphate 
Panthenol 
Vitamin A Palmitate 
Tocopherol 
Citrus Maxima Fruit Rind Oil 
Rosewood Oil 
Lavender Oil 
Thyme Oil 
Aluminum Hydroxide 
Edetate Disodium 
Xanthan Gum 
Propylparaben 
Linalool, (+/-)- 
Polyoxyl 20 Cetostearyl Ether 
Sodium Pyrrolidone Carboxylate 
Sodium Lactate 
Sorbitol 
Magnesium Aluminum Silicate 
Diazolidinyl Urea 
Methylparaben 
Talc 
Geraniol 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
Product Characteristics
ColorBROWN (Light Brown) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:21839-011-501 TUBE (TUBE) 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: 08/2011
 
Gordon Laboratories, Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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