FDA Label for Zo Medical Zo Non-hydroquinone Hyperpigmentation System For Skin Brightening
View Indications, Usage & Precautions
Zo Medical Zo Non-hydroquinone Hyperpigmentation System For Skin Brightening Product Label
The following document was submitted to the FDA by the labeler of this product Zo Skin Health, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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Drug Facts
DIST BY
ZO Skin Health, Inc. Irvine, CA 92618
Active Ingredient
Titanium Dioxide 8%
Purpose
Sunscreen
Uses
- Helps prevent sunburn.
- If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
Warnings
For external use only.
Otc - Do Not Use
Do not use on damaged or broken skin.
Otc - Stop Use
Stop and ask a doctor if rash occurs.
Otc - When Using
When using this product keep out of eyes. Rinse with water to remove.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.
Other Information
- Store product in a cool place away from direct heat and sunlight.
- You may report a serious adverse reaction to: 5 Technology Dr. #100, Irvine, CA 92618
Directions
- For full protection, apply liberally 15 minutes before sun exposure.
- Use a water resistant sunscreen if swimming or sweating.
- Reapply at least every 2 hours.
- For children under 6 months of age: ask a doctor.
- Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including:
- Limit time in the sun, especially from 10 a.m.- 2 p.m.- Wear long-sleeved shirts, pants, hats and sunglasses.
- Apply to all skin exposed to the sun.
Inactive Ingredients
Water, Aluminum Hydroxide, Stearic Acid, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Cyclopentasiloxane, Phenyl Trimethicone, Styrene/Acrylates Copolymer, Pentylene Glycol, Dimethicone, Glycerin, Isodecyl Neopentanoate, Diisopropyl Sebacate, Lauryl Lactate, Polyacrylamide, Disodium EDTA, Phytosphingosine, Ceteareth-20, Cetearyl Alcohol, PEG-100 Stearate, Glyceryl Stearate, Sodium Dihydroxycetyl Phosphate, Hydrogenated Palm Glycerides, Melanin, Ethylhexylglycerin, Erythritol, Homarine HCL, Sodium Benzoate, Potassium Sorbate, Phenoxyethanol, Caprylyl Glycol, Chlorphenesin, Nephelium Lappaceum Peel Extract, Glycine Soja (Soybean) extract, Silica, C13-14 Isoparaffin, Laureth-7.
Principal Display Panel - Kit Carton
ZO® MEDICAL
BY ZEIN OBAGI MD
NDC 42851-158-60
ZO® NON-HYDROQUINONE HYPERPIGMENTATION SYSTEM
For Skin Brightening
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