ZO MEDICAL OCLIPSE-C BROAD-SPECTRUM SUNSCREEN SPF 50- titanium dioxide and zinc oxide 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
National Drug Code 42851-058-21

Drug Facts

Active ingredientsPurpose
Titanium Dioxide 5.7%Sunscreen
Zinc Oxide 4.9%Sunscreen

Uses

  • Helps prevent sunburn.

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

  • 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

  • Protect the product in this container from excessive heat and direct sun.
  • You may report a serious adverse reaction to: 5 Technology Dr. Irvine, CA 92618

Inactive ingredients

Water, C12-15 Alkyl Benzoate, Squalane, Cyclopentasiloxane, Propanediol, Styrene/Acrylates Copolymer, PPG-3 Isostearyl Methyl Ether, PEG/PPG-17/6 Copolymer, Neopentyl Glycol Diheptanoate, Acrylates Copolymer, Argania Spinosa Kernel Oil, Silica, Cetearyl Alcohol, Tocopheryl Acetate, Alumina, PEG-100 Stearate, Glyceryl Stearate, Phenoxyethanol, Polyhydroxystearic Acid, Ceteareth-20, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Methicone, Isohexadecane, Bisabolol, PEG-8 Laurate, Caprylyl Glycol, Triethoxycaprylylsilane, Polymethyl Methacrylate, Pentylene Glycol, Chlorphenesin, Glycerin, Disodium EDTA, Helianthus Annuus (Sunflower) Seed Oil, Polysorbate 60, Erythritol, Sorbitan isostearate, Melanin, Iron Oxides, Glycine Soja (Soybean) Seed Extract, Polyglyceryl-5 Trioleate, Ethyl Ferulate, 1,2-Hexanediol, Retinyl Palmitate, Ascorbic Acid, Nephelium Lappaceum Peel Extract, Potassium Sorbate, Ethylhexylglycerin, Beta-Glucan, Sodium Benzoate, Rosmarinus Officinalis (Rosemary) Leaf Extract, Homarine HCL, Tocopherol, Disodium Uridine Phosphate, Citric Acid.

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

PRINCIPAL DISPLAY PANEL - 118 g Bottle Carton

ZO ®MEDICAL
BY ZEIN OBAGI MD

OCLIPSE-C™
Broad-Spectrum
Sunscreen SPF 50

UVA/UVB/HEV/IR-A
Protection

ZOX 12

NDC 42851-058-21

Net Wt. 118 g / 4.0 Oz.

Principal Display Panel - 118 g Bottle Carton
ZO MEDICAL OCLIPSE-C BROAD-SPECTRUM SUNSCREEN SPF 50 
titanium dioxide and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42851-058
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE57 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE49 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
SQUALANE (UNII: GW89575KF9)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
PROPANEDIOL (UNII: 5965N8W85T)  
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)  
PEG/PPG-17/6 COPOLYMER (UNII: P5QZM4T259)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
ARGAN OIL (UNII: 4V59G5UW9X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
PEG-100 STEARATE (UNII: YD01N1999R)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
LEVOMENOL (UNII: 24WE03BX2T)  
PEG-8 LAURATE (UNII: 762O8IWA10)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
GLYCERIN (UNII: PDC6A3C0OX)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
ERYTHRITOL (UNII: RA96B954X6)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
SOYBEAN (UNII: L7HT8F1ZOD)  
ETHYL FERULATE (UNII: 5B8915UELW)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
NEPHELIUM LAPPACEUM FRUIT RIND (UNII: Y0513T90FO)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
ROSEMARY (UNII: IJ67X351P9)  
HOMARINE HYDROCHLORIDE (UNII: 8866LNG61N)  
TOCOPHEROL (UNII: R0ZB2556P8)  
URIDINE MONOPHOSPHATE DISODIUM (UNII: KD8E20071T)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42851-058-211 in 1 CARTON02/01/201702/01/2020
1118 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/01/201702/01/2020
Labeler - ZO Skin Health, Inc. (826468527)

Revised: 5/2022
 
ZO Skin Health, Inc.