Indications and 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.
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.
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 ot...
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
Drug Facts
Titanium Dioxide 8%
Sunscreen
For external use only.
Do not use on damaged or broken skin.
Stop and ask a doctor if rash occurs.
When using this product keep out of eyes. Rinse with water to remove.
Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.
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.
DIST BY
ZO Skin Health, Inc. Irvine, CA 92618
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 777d68c6-a5ab-e06c-d314-677b0b9af0c8 | Product name | 2 | 20240508 |
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| c5cd4727-ac49-4409-82b1-5bd8006c3ec7 | Product name | 1 | 20171122 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 42851-158-60 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-2008-f424-e053-dadaa90a57ce | ZO ® MEDICAL ZO ® NON-HYDROQUINONE HYPERPIGMENTATION SYSTEM For Skin Brightening |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 42851-052-60 | ZO MEDICAL ZO NON-HYDROQUINONE HYPERPIGMENTATION SYSTEM For Skin Brightening | 60 g in 1 TUBE | LOTION | 60 g | 0.08 g in 1g | 1 |
| 42851-158-60 | ZO MEDICAL ZO NON-HYDROQUINONE HYPERPIGMENTATION SYSTEM For Skin Brightening | 1 in 1 CARTON | KIT | 1 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 42851-052 | ZO MEDICAL ZO NON-HYDROQUINONE HYPERPIGMENTATION SYSTEM FOR SKIN BRIGHTENING (TITANIUM DIOXIDE) KIT [ZO SKIN HEALTH, INC.] | 1 | Legacy NDC | 20160714_73246324-eede-4933-9921-bb2b59642964.zip |
| 42851-158 | ZO MEDICAL ZO NON-HYDROQUINONE HYPERPIGMENTATION SYSTEM FOR SKIN BRIGHTENING (TITANIUM DIOXIDE) KIT [ZO SKIN HEALTH, INC.] | 1 | Legacy NDC, 2 package rows | 20160714_73246324-eede-4933-9921-bb2b59642964.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 42851-158 | 42851-158-60 |
| 42851-052 | 42851-052-60 |
Every source-derived ingredient row is available through these pages.
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 50473cf6-b9d0-4865-8767-358eb8b79808 | 73246324-eede-4933-9921-bb2b59642964 | 2016-07-12 | Warnings | 50473cf6-b9d0-4865-8767-358eb8b79808 73246324-eede-4933-9921-bb2b59642964 |
Adverse event summaries are temporarily unavailable. Other product information remains available.