ZO SKIN HEALTH OCLIPSE SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 UVA/UVB PROTECTION- titanium dioxide lotion

ZO SKIN HEALTH OCLIPSE Sunscreen plus Primer Broad-Spectrum SPF 30 UVA/UVB Protection by

Drug Labeling and Warnings

ZO SKIN HEALTH OCLIPSE Sunscreen plus Primer Broad-Spectrum SPF 30 UVA/UVB Protection 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 ingredients

Titanium Dioxide, 8.2%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• higher SPF gives more sunburn protection
• provides high protection against sunburn

Warnings

For external use only

When using this product

• keep out of eyes. Rinse with water to remove

Stop use and ask a doctor if

• rash or irritation develops and lasts

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
• Children under 6 months of age: ask a doctor
• Reapply as needed or after towel drying, swimming, or sweating

Other information

High sun protection product.

Sun alert

Limiting sun exposure, wearing protective clothing and using sunscreens may reduce the reisks of skin aging, skin cancer and other harmful effects of the sun.

Protect the product in this container from excessive heat and direct sunlight. You may report a serious adverse reaction to: 1 Technology Dr. B123, Irvine, CA 92618

Inactive ingredients

Cyclopentasiloxane, Dimethicone Crosspolymer, Phenyl Trimethicone, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Dimethiconol,Aluminum Hydroxide, Stearic Acid, Dimethicone/Vinyl Dimethicone Crosspolymer, Tribehenin, Helianthus Annuus Seed Oil, Polymethyl Methacrylate, Water (Aqua), Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Polyglyceryl-4 Isostearate, Glycerin, Glycine Soja Seed Extract, Caprylic/Capric Triglyceride, Behenyl Behenate, Squalane, Tocopheryl Acetate, Melanin, Ethyl Ferulate, Polyglyceryl-5 Trioleate, Triethoxycaprylylsilane, Ascorbic Acid, Methylisothiazolinone, Retinyl Palmitate, Pentylene Glycol, Rosmarinus Officinalis Leaf Extract, Ethylhexylglycerin, Disodium Uridine Phosphate, Tocopherol, Myristoyl Pentapeptide-8, Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499).

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

ZO® SKIN HEALTH

BY ZEIN OBAGI, MD

NDC: 42851-053-03

OCLIPSE®

SUNSCREEN + PRIMER
BROAD-SPECTRUM SPF 30
UVA/UVB PROTECTION

30 mL / 1 Fl. Oz.

INGREDIENTS AND APPEARANCE

ZO SKIN HEALTH OCLIPSE SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 UVA/UVB PROTECTION 
titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42851-053
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	82 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
DIMETHICONOL (40 CST) (UNII: 343C7U75XW)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
SUNFLOWER OIL (UNII: 3W1JG795YI)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
WATER (UNII: 059QF0KO0R)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
GLYCERIN (UNII: PDC6A3C0OX)
SOYBEAN GERM (UNII: JBW2VHD14M)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
BEHENYL BEHENATE (UNII: K8NU647RJ0)
SQUALANE (UNII: GW89575KF9)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MELAMINE (UNII: N3GP2YSD88)
ETHYL FERULATE (UNII: 5B8915UELW)
POLYGLYCERYL-3 DIOLEATE (UNII: D08AL46IU2)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ROSEMARY (UNII: IJ67X351P9)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
URIDINE MONOPHOSPHATE DISODIUM (UNII: KD8E20071T)
TOCOPHEROL (UNII: R0ZB2556P8)
MYRISTOYL PENTAPEPTIDE-4 (UNII: PMA59A699X)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42851-053-03	1 in 1 CARTON	10/01/2014
1		30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2	NDC: 42851-053-01	1 in 1 CARTON	10/01/2014
2		15 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
3	NDC: 42851-053-07	1 in 1 CARTON	12/01/2015
3		75 mL 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	09/01/2014

Labeler - ZO Skin Health, Inc. (826468527)

Establishment
Name	Address	ID/FEI	Business Operations
THIBIANT INTERNATIONAL, INC.		083913913	MANUFACTURE(42851-053)