ZO MEDICAL OCLIPSE-C BROAD-SPECTRUM SUNSCREEN SPF 50- titanium dioxide and zinc oxide 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., Thibiant International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
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.

SPL UNCLASSIFIED SECTION

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

ZOX12™

NDC: 42851-058-21

Net Wt. 118 g / 4.0 Oz.

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42851-058
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	57 mg  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	49 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42851-058-21	1 in 1 CARTON	02/01/2017
1		118 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	02/01/2017

Labeler - ZO Skin Health, Inc. (826468527)

Establishment
Name	Address	ID/FEI	Business Operations
Thibiant International, Inc.		083913913	MANUFACTURE(42851-058)