![ZO SKIN HEALTH OCLIPSE SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 UVA/UVB PROTECTION (TITANIUM DIOXIDE) LOTION [ZO SKIN HEALTH, INC.]](https://medic.hrt.org//dailymed/images/e5851c56-dc29-475b-aa21-33823b0674d6/US Oclipse Sunscreen SPF30 Gen 2 Box.jpg)
| NDC | 42851-053-01, 42851-053-03, 42851-053-07 |
| Set ID | e5851c56-dc29-475b-aa21-33823b0674d6 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | ZO Skin Health, Inc. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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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
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Directions
- Apply liberally 15 minutes before sun exposure.
- Use a water resistant sunscreen if swimming or sweating.
- Children under 6 months: Ask a doctor.
- Reapply at least every two hours.
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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
- Other information
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Inactive ingredients
Cyclopentasiloxane, Dimethicone Crosspolymer, Phenyl Trimethicone, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Stearic Acid, Aluminum Hydroxide, Dimethicone/Vinyl Dimethicone Crosspolymer, Tribehenin, Helianthus Annuus (Sunflower) Seed Oil, Polymethyl Methacrylate, Water, Polyglyceryl-4 Isostearate, Hexyl Laurate, Cetyl PEG/PPG-10/1 Dimethicone, Glycerin, Dimethiconol, Phenoxyethanol, Squalane, Caprylic/Capric Triglyceride, Caprylyl Glycol, Chlorphenesin, Tocopheryl Acetate, Melanin, Behenyl Behenate, Triethoxycaprylylsilane, Polyglyceryl-5 Trioleate, Ethyl Ferulate, Glycine Soja (Soybean) Seed Extract, Calcium Chloride, Retinyl Palmitate, Pentylene Glycol, Ascorbic Acid, Rosmarinus Officinalis (Rosemary) Leaf Extract, Potassium Sorbate, Ethylhexylglycerin, Myristoyl Pentapeptide-8, Tocopherol, Disodium Uridine Phosphate, Pentaerythrityl Tetra-di-t-butyl, Hydroxyhydrocinnamate, Iron Oxides.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
ZO SKIN HEALTH OCLIPSE SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 UVA/UVB PROTECTION
titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42851-053 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 82 mg in 1 mL Inactive Ingredients Ingredient Name Strength TRIBEHENIN (UNII: 8OC9U7TQZ0) CAPRYLYL GLYCOL (UNII: 00YIU5438U) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) PENTYLENE GLYCOL (UNII: 50C1307PZG) TOCOPHEROL (UNII: R0ZB2556P8) DIMETHICONOL (40 CST) (UNII: 343C7U75XW) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) SQUALANE (UNII: GW89575KF9) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) GLYCERIN (UNII: PDC6A3C0OX) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) HEXYL LAURATE (UNII: 4CG9F9W01Q) BEHENYL BEHENATE (UNII: K8NU647RJ0) CALCIUM CHLORIDE (UNII: M4I0D6VV5M) ASCORBIC ACID (UNII: PQ6CK8PD0R) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) URIDINE MONOPHOSPHATE DISODIUM (UNII: KD8E20071T) CHLORPHENESIN (UNII: I670DAL4SZ) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) FERRIC OXIDE RED (UNII: 1K09F3G675) STEARIC ACID (UNII: 4ELV7Z65AP) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X) SUNFLOWER OIL (UNII: 3W1JG795YI) WATER (UNII: 059QF0KO0R) POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11) ETHYL FERULATE (UNII: 5B8915UELW) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) ROSEMARY (UNII: IJ67X351P9) SOYBEAN (UNII: L7HT8F1ZOD) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42851-053-03 1 in 1 CARTON 01/02/2018 1 30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 2 NDC:42851-053-01 15 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 01/02/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 01/02/2018 Labeler - ZO Skin Health, Inc. (826468527) Establishment Name Address ID/FEI Business Operations Thibiant International, Inc. 083913913 manufacture(42851-053)
