ZO MEDICAL OCLIPSE-C BROAD-SPECTRUM SUNSCREEN SPF 50- titanium dioxide lotion 
ZO Skin Health, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ZO ® MEDICAL OCLIPSE-C™ Broad-Spectrum Sunscreen SPF 50

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.

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.

Principal Display Panel - 118 g Tube Carton
ZO MEDICAL OCLIPSE-C BROAD-SPECTRUM SUNSCREEN SPF 50 
titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42851-052
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.08 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42851-052-121 in 1 CARTON
1118 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/01/201203/01/2017
Labeler - ZO Skin Health, Inc. (826468527)
Establishment
NameAddressID/FEIBusiness Operations
Sanitor Corporation797472792manufacture(42851-052)

Revised: 3/2023
 
ZO Skin Health, Inc.