OCLIPSE SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 UVA/UVB PROTECTION- titanium dioxide and zinc oxide lotion

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

Drug Labeling and Warnings

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., Owen Biosciences, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Titanium Dioxide 10.2%	Sunscreen
Zinc Oxide 3.7%	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

• Apply liberally 15 minutes before sun exposure.
• Use a water resistant sunscreen if swimming or sweating.
• Reapply at least every 2 hours.
• Children under 6 months: 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 sunlight.
• You may report a serious adverse reaction to: 1 Technology Dr. B123, Irvine, CA 92618

Inactive ingredients

Cyclopentasiloxane, Cyclotetrasiloxane, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Melanin, Tribehenin, Calcium Behenate, Sorbitan Isostearate, Myristoyl Pentapeptide-8, Dimethiconol, Alumina, PEG-10 Dimethicone, Methicone, Iron Oxides.

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

OCLIPSE®

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

beverly hills

30 mL / 1 Fl. Oz.

INGREDIENTS AND APPEARANCE

OCLIPSE SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 UVA/UVB PROTECTION 
titanium dioxide and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42851-051
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	102 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	37 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 4 (UNII: CZ227117JE)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
CALCIUM BEHENATE (UNII: J5VFA9V6YG)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
DIMETHICONOL (40 CST) (UNII: 343C7U75XW)
ALUMINUM OXIDE (UNII: LMI26O6933)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
METHICONE (20 CST) (UNII: 6777U11MKT)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42851-051-03	1 in 1 CARTON
1		30 mL in 1 BOTTLE, PUMP
2	NDC: 42851-051-01	15 mL in 1 BOTTLE, PUMP

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
Owen Biosciences, Inc.		790003045	MANUFACTURE(42851-051)