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 o...
Store product in a cool place away from direct heat and sunlight You may report a serious adverse reaction to: 1 Technology Dr. B123, 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 (Aqua), Cyclopentasiloxane, Phenyl Trimethicone, Styrene/Acrylates Copolymer, Pentylene Glycol, Dimethicone, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Diisopropyl Sebacate, Glycerin, Isodecyl Neopentanoate, Lauryl Lactate, Polyacrylamide, Sodium Dihydroxycetyl Phosphate, Phytosphingosine, Hydrogenated Palm Glycerides, Melanin, Erythritol, Homarine HCL, Nephelium Lappaceum Branch/Fruit/Leaf Extract, Silica, Glycine Soja (Soybean) Seed Extract, C13-14 Isoparaffin, Laureth-7, Ceteareth-20, Cetearyl Alcohol, PEG-100 Stearate, Glyceryl Stearate, Aluminum Hydroxide, Stearic Acid, Disodium EDTA, Phenoxyethanol, Caprylyl Glycol, Chlorphenesin.
DIST BY
ZO Skin Health, Inc. Irvine, CA 92618
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 42851-052-12 | 2023-03-25 | C162847 | 48780-1 | 9d75b9d0-b5ae-f424-e053-dadaa90a57ce | ZO ® MEDICAL OCLIPSE-C™ Broad-Spectrum Sunscreen SPF 50 |
| 42851-052-12 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-b5ae-f424-e053-dadaa90a57ce | ZO ® MEDICAL OCLIPSE-C™ Broad-Spectrum Sunscreen SPF 50 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Titanium Dioxide | ACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| Titanium Dioxide | ACTIVE MOIETY | 15FIX9V2JP | 1 | |
| Aluminum Hydroxide | INACTIVE INGREDIENT | 5QB0T2IUN0 | 1 | |
| C13-14 Isoparaffin | INACTIVE INGREDIENT | E4F12ROE70 | 1 | |
| Caprylyl Glycol | INACTIVE INGREDIENT | 00YIU5438U | 1 | |
| Cetostearyl Alcohol | INACTIVE INGREDIENT | 2DMT128M1S | 1 | |
| Chlorphenesin | INACTIVE INGREDIENT | I670DAL4SZ | 1 | |
| Cyclomethicone 5 | INACTIVE INGREDIENT | 0THT5PCI0R | 1 | |
| Diisopropyl Sebacate | INACTIVE INGREDIENT | J8T3X564IH | 1 | |
| Dimethicone | INACTIVE INGREDIENT | 92RU3N3Y1O | 1 | |
| Edetate Disodium | INACTIVE INGREDIENT | 7FLD91C86K | 1 | |
| Erythritol | INACTIVE INGREDIENT | RA96B954X6 | 1 | |
| Glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| Homarine Hydrochloride | INACTIVE INGREDIENT | 8866LNG61N | 1 | |
| Hydrogenated Palm Glycerides | INACTIVE INGREDIENT | YCZ8EM144Q | 1 | |
| Isodecyl Neopentanoate | INACTIVE INGREDIENT | W60VYE24XC | 1 | |
| Laureth-7 | INACTIVE INGREDIENT | Z95S6G8201 | 1 | |
| Lauryl Lactate | INACTIVE INGREDIENT | G5SU0BFK7O | 1 | |
| PEG-100 stearate | INACTIVE INGREDIENT | YD01N1999R | 1 | |
| Pentylene Glycol | INACTIVE INGREDIENT | 50C1307PZG | 1 | |
| Phenoxyethanol | INACTIVE INGREDIENT | HIE492ZZ3T | 1 | |
| Phenyl Trimethicone | INACTIVE INGREDIENT | DR0K5NOJ4R | 1 | |
| Phytosphingosine | INACTIVE INGREDIENT | GIN46U9Q2Q | 1 | |
| Polyoxyl 20 Cetostearyl Ether | INACTIVE INGREDIENT | YRC528SWUY | 1 | |
| Silicon Dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| Sodium Dihydroxycetyl Phosphate | INACTIVE INGREDIENT | YWI33EV595 | 1 | |
| Soybean | INACTIVE INGREDIENT | L7HT8F1ZOD | 1 | |
| Stearic Acid | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 42851-052 | 42851-052-12 |
Every source-derived ingredient row is available through these pages.
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| Glycerin | GLYCERIN | PDC6A3C0OX | SOAP / TOPICAL | 0.76 %w/w | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRAVASCULAR | 0.48 mg | ||
| Polyoxyl 20 Cetostearyl Ether | POLYOXYL 20 CETOSTEARYL ETHER | YRC528SWUY | LOTION / TOPICAL | 71 mg | ||
| Aluminum Hydroxide | ALUMINUM HYDROXIDE | 5QB0T2IUN0 | OINTMENT / TOPICAL | NA | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, COATED / ORAL | 176 mg | ||
| Cetostearyl Alcohol | CETOSTEARYL ALCOHOL | 2DMT128M1S | AEROSOL, FOAM / TOPICAL | 21 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / AURICULAR (OTIC) | 25 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRA-ARTICULAR | 0.05 %w/v | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TAMPON / VAGINAL | NA | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAMUSCULAR | 450 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / BUCCAL | 34 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | EMULSION / OPHTHALMIC | 3 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / BUCCAL | 3 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | OINTMENT / TOPICAL | NA | ||
| Cyclomethicone 5 | CYCLOMETHICONE 5 | 0THT5PCI0R | AEROSOL, FOAM / TOPICAL | 144 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | AEROSOL, FOAM / TOPICAL | 21 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | AEROSOL / TOPICAL | 3 %w/w | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | SUPPOSITORY / RECTAL | 14 mg | ||
| Polyoxyl 20 Cetostearyl Ether | POLYOXYL 20 CETOSTEARYL ETHER | YRC528SWUY | AEROSOL, FOAM / TOPICAL | 374 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | CREAM, AUGMENTED / TOPICAL | 2 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | OINTMENT / TOPICAL | 15 %w/w | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | LIQUID / ORAL | 0.5 mg/1ml | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | CREAM / VAGINAL | 3 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | SYSTEM / IONTOPHORESIS | 0.1 mg | ||
| Phenoxyethanol | PHENOXYETHANOL | HIE492ZZ3T | GEL / TOPICAL | 14 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / TOPICAL | 1971 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | DOUCHE / VAGINAL | 1 %w/w | ||
| Cetostearyl Alcohol | CETOSTEARYL ALCOHOL | 2DMT128M1S | CREAM / TOPICAL | 1428 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | PASTE / DENTAL | 20 %w/w | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | SHAMPOO / TOPICAL | 1 %w/w | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED / ORAL | 176 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION / AURICULAR (OTIC) | 0.05 %w/w | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | TABLET, EXTENDED RELEASE / ORAL | 10 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION, SOLUTION / INTRAMUSCULAR | 4 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SPRAY, METERED / NASAL | 13 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SUSPENSION / ORAL | 2553 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | SPRAY, METERED / NASAL | 4 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | LOZENGE / ORAL | 120 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | SYRUP / ORAL | 40 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 225 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED / ORAL | 3 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / TOPICAL | 6 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION / AURICULAR (OTIC) | 0.01 %w/v | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION / INTRADERMAL | 1.6 %w/v | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | EMULSION / INTRAVENOUS | 2.2 %w/v | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | PELLET / SUBCUTANEOUS | 0.97 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, LIQUID FILLED / ORAL | 106 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER / RESPIRATORY (INHALATION) | NA | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | 0.4 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | POWDER, FOR SUSPENSION / ORAL | 285 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | TABLET / ORAL | 42 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INFILTRATION | 6 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | SUSPENSION / ORAL | 400 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE / ORAL | 5000 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | LIQUID / TOPICAL | 2.5 %w/w | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | CAPSULE, EXTENDED RELEASE / ORAL | 64 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | GEL / TOPICAL | 500 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / VAGINAL | 8 %w/w | ||
| Polyoxyl 20 Cetostearyl Ether | POLYOXYL 20 CETOSTEARYL ETHER | YRC528SWUY | CREAM / TOPICAL | 180 mg | ||
| Stearic Acid | STEARIC ACID | 4ELV7Z65AP | SOLUTION / TOPICAL | NA |
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 |
|---|---|---|---|---|---|---|
| f79a9db5-5ad5-342e-e053-6294a90a9200 | 6f64dd44-b54f-497b-adb4-7655f0418070 | 2023-03-23 | Warnings | 6f64dd44-b54f-497b-adb4-7655f0418070 |
Adverse event summaries are temporarily unavailable. Other product information remains available.