OTC Medication Information: Ultra Sensitive Faceblock SPF 25

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.

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
(click image for full-size original)
ULTRA SENSITIVE FACEBLOCK SPF 25
titanium dioxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:21839-011
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Titanium Dioxide (Titanium Dioxide) Titanium Dioxide 4000 mg in 50 mL
Inactive Ingredients
Ingredient Name Strength
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
Color BROWN (Light Brown) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:21839-011-50 1 TUBE (TUBE) in 1 BOX contains a TUBE
1 50 mL in 1 TUBE This package is contained within the BOX (21839-011-50)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 09/01/2009
Labeler — Gordon Laboratories, Inc (008328619)

Revised: 08/2011 Gordon Laboratories, Inc

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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