Ultra Sensitive Faceblock Spf 25
FDA Label NDC 21839-011

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Gordon Laboratories, Inc for the product Ultra Sensitive Faceblock Spf 25 (NDC 21839-011). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, warnings, otc - stop use, otc - do not use, other ingredients, other, principal display panel - 50 ml bottle carton, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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.

Otc - Stop Use

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

Otc - Do Not Use

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).

Other

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)

Principal Display Panel (50 mL Bottle Carton)

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