ZO MEDICAL OCLIPSE-C BROAD-SPECTRUM SUNSCREEN SPF 50- titanium dioxide lotion

ZO MEDICAL OCLIPSE-C Broad-Spectrum Sunscreen SPF 50 by

Drug Labeling and Warnings

ZO MEDICAL OCLIPSE-C Broad-Spectrum Sunscreen SPF 50 by is a Otc medication manufactured, distributed, or labeled by ZO Skin Health, Inc., Sanitor Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

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.

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.

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

• 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

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

DIST BY
ZO Skin Health, Inc. Irvine, CA 92618

PRINCIPAL DISPLAY PANEL - 118 g Tube Carton

ZO®MEDICAL

BY ZEIN OBAGI, MD

OCLIPSE-C™
Broad-Spectrum Sunscreen
SPF 50

Net Wt. 118 g / 4.0 Oz.

INGREDIENTS AND APPEARANCE

ZO MEDICAL OCLIPSE-C BROAD-SPECTRUM SUNSCREEN SPF 50 
titanium dioxide lotion

Product 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)