ZO SKIN HEALTH SUNSMART TRIPLE PROTECTION PROGRAM NATURAL MELANIN AND ANTIOXIDANT DEFENDERS WITH SUNSCREEN PLUS PRIMER SPF 30- titanium dioxide and zinc oxide kit

ZO SKIN HEALTH by

Drug Labeling and Warnings

ZO SKIN HEALTH by is a Otc medication manufactured, distributed, or labeled by ZO Skin Health, Inc., Owen Biosciences, PakLab, 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/Vinyl Dimethicone Crosspolymer, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Dimethicone Crosspolymer, Melanin,Tribehenin, Calcium Behenate, Sorbitan Isostearate, Dimethiconol, Alumina,Laureth-23, Methicone, PEG-10 Dimethicone, PPG-2 Myristyl Ether Propionate, Propylparaben, Methylparaben, Myristoyl Pentapeptide-8, Iron Oxide (CI 77492).

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - Kit Carton

ZO® SKIN HEALTH
BY ZEIN OBAGI, MD

SunSmart
TRIPLE PROTECTION PROGRAM

Natural Melanin and Antioxidant
Defenders with Sunscreen + Primer
SPF 30

NDC: 42851-157-03

beverly hills

ANTI-AGING COMBO PACK

INGREDIENTS AND APPEARANCE

ZO SKIN HEALTH  SUNSMART TRIPLE PROTECTION PROGRAM NATURAL MELANIN AND ANTIOXIDANT DEFENDERS WITH SUNSCREEN PLUS PRIMER SPF 30
titanium dioxide and zinc oxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42851-157

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42851-157-03	1 in 1 CARTON

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, PUMP	30 mL
Part 2	1 BOTTLE, PUMP	30 mL

Part 1 of 2

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

Product Information
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)
LAURETH-23 (UNII: N72LMW566G)
METHICONE (20 CST) (UNII: 6777U11MKT)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
PPG-2 MYRISTYL ETHER PROPIONATE (UNII: 88R97D8U8A)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
METHYLPARABEN (UNII: A2I8C7HI9T)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42851-051-03	30 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

Part 2 of 2

OSSENTIAL DAILY POWER DEFENSE ANTI-AGING FORMULA 
cleansing (cold creams, cleansing lotions, liquids, and pads) lotion

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	CETEARYL ISONONANOATE (UNII: P5O01U99NI)
INGR	CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
INGR	CYCLOMETHICONE 6 (UNII: XHK3U310BA)
INGR	PENTYLENE GLYCOL (UNII: 50C1307PZG)
INGR	RETINOL (UNII: G2SH0XKK91)
INGR	EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
INGR	POLYSORBATE 20 (UNII: 7T1F30V5YH)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	STEARETH-20 (UNII: L0Q8IK9E08)
INGR	CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
INGR	JOJOBA BUTTER (UNII: XIA46H803R)
INGR	VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	CURDLAN (UNII: 6930DL209R)
INGR	LACTOSE (UNII: J2B2A4N98G)
INGR	ORANGE OIL (UNII: AKN3KSD11B)
INGR	MANDARIN OIL (UNII: NJO720F72R)
INGR	LEMON OIL (UNII: I9GRO824LL)
INGR	PEPPERMINT OIL (UNII: AV092KU4JH)
INGR	MIMOSA TENUIFLORA BARK (UNII: 515MQE449I)
INGR	ARABIDOPSIS THALIANA (UNII: AI3L60HQ81)
INGR	C14-22 ALCOHOLS (UNII: B1K89384RJ)
INGR	CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
INGR	C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)
INGR	POWDERED CELLULOSE (UNII: SMD1X3XO9M)
INGR	BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
INGR	PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)
INGR	PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)
INGR	CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
INGR	HYPROMELLOSES (UNII: 3NXW29V3WO)
INGR	HEXYLENE GLYCOL (UNII: KEH0A3F75J)
INGR	EDETATE DISODIUM (UNII: 7FLD91C86K)
INGR	CAPRYLYL GLYCOL (UNII: 00YIU5438U)
INGR	ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	LIMONENE, (+/-)- (UNII: 9MC3I34447)
INGR	ULTRAMARINE BLUE (UNII: I39WR998BI)
INGR	EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		30 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
COSMETIC		01/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/01/2014

Labeler - ZO Skin Health, Inc. (826468527)

Establishment
Name	Address	ID/FEI	Business Operations
Owen Biosciences		790003045	MANUFACTURE(42851-157)

Establishment
Name	Address	ID/FEI	Business Operations
PakLab, Inc.		177711082	MANUFACTURE(42851-157)