ULTRA SENSITIVE FACEBLOCK SPF 25- titanium dioxide lotion

Ultra Sensitive Faceblock SPF 25 by

Drug Labeling and Warnings

Ultra Sensitive Faceblock SPF 25 by is a Otc medication manufactured, distributed, or labeled by Gordon Laboratories, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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).

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	4000 mg  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	BROWN (Light Brown)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21839-011-50	1 in 1 BOX
1		50 mL in 1 TUBE

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)