NDC | 42851-052-12 |
Set ID | 6f64dd44-b54f-497b-adb4-7655f0418070 |
Category | HUMAN OTC DRUG LABEL |
Packager | ZO Skin Health, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
-
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
-
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.
- Other information
-
Inactive ingredients
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.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 118 g Tube Carton
-
INGREDIENTS AND APPEARANCE
ZO MEDICAL OCLIPSE-C BROAD-SPECTRUM SUNSCREEN SPF 50
titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42851-052 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.08 g in 1 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Cyclomethicone 5 (UNII: 0THT5PCI0R) Phenyl Trimethicone (UNII: DR0K5NOJ4R) Pentylene Glycol (UNII: 50C1307PZG) Dimethicone (UNII: 92RU3N3Y1O) Diisopropyl Sebacate (UNII: J8T3X564IH) Glycerin (UNII: PDC6A3C0OX) Isodecyl Neopentanoate (UNII: W60VYE24XC) Lauryl Lactate (UNII: G5SU0BFK7O) Sodium Dihydroxycetyl Phosphate (UNII: YWI33EV595) Phytosphingosine (UNII: GIN46U9Q2Q) Hydrogenated Palm Glycerides (UNII: YCZ8EM144Q) Erythritol (UNII: RA96B954X6) Homarine Hydrochloride (UNII: 8866LNG61N) Silicon Dioxide (UNII: ETJ7Z6XBU4) Soybean (UNII: L7HT8F1ZOD) C13-14 Isoparaffin (UNII: E4F12ROE70) Laureth-7 (UNII: Z95S6G8201) Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY) Cetostearyl Alcohol (UNII: 2DMT128M1S) PEG-100 stearate (UNII: YD01N1999R) Aluminum Hydroxide (UNII: 5QB0T2IUN0) Stearic Acid (UNII: 4ELV7Z65AP) Edetate Disodium (UNII: 7FLD91C86K) Phenoxyethanol (UNII: HIE492ZZ3T) Caprylyl Glycol (UNII: 00YIU5438U) Chlorphenesin (UNII: I670DAL4SZ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42851-052-12 1 in 1 CARTON 1 118 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 01/01/2012 Labeler - ZO Skin Health, Inc. (826468527) Establishment Name Address ID/FEI Business Operations Sanitor Corporation 797472792 MANUFACTURE(42851-052)