ZO SKIN HEALTH  OSSENTIAL DAILY POWER DEFENSE ANTI-AGING FORMULA AND OCLIPSE SUNSCREEN PLUS PRIMER BROAD SPECTRUM SPF 30 UVA/UVB PROTECTION - titanium dioxide and zinc oxide 
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.

----------

ZO® SKIN HEALTH
OSSENTIAL® DAILY POWER DEFENSE ANTI-AGING FORMULA + OCLIPSE® SUNSCREEN + PRIMER BROAD SPECTRUM SPF 30 UVA/UVB PROTECTION

Drug Facts

Active ingredientsPurpose
Titanium Dioxide 10.2%Sunscreen
Zinc Oxide 3.7%Sunscreen

Uses

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

Other information

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).

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

PRINCIPAL DISPLAY PANEL - Kit Carton

ZO® SKIN HEALTH
BY ZEIN OBAGI, MD

OSSENTIAL®
DAILY POWER DEFENSE
ANTI-AGING FORMULA
+
OCLIPSE®
SUNSCREEN + PRIMER
BROAD-SPECTRUM SPF 30
UVA/UVB PROTECTION

NDC 42851-155-03

beverly hills

ANTI-AGING COMBO PACK

PRINCIPAL DISPLAY PANEL - Kit Carton
ZO SKIN HEALTH  OSSENTIAL DAILY POWER DEFENSE ANTI-AGING FORMULA AND OCLIPSE SUNSCREEN PLUS PRIMER BROAD SPECTRUM SPF 30 UVA/UVB PROTECTION
titanium dioxide and zinc oxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42851-155
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42851-155-031 in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, PUMP 30 mL
Part 21 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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) TITANIUM DIOXIDE102 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) ZINC OXIDE37 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42851-051-0330 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/01/2012
Part 2 of 2
OSSENTIAL DAILY POWER DEFENSE ANTI-AGING FORMULA 
cleansing (cold creams, cleansing lotions, liquids, and pads) lotion
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRCETEARYL ISONONANOATE (UNII: P5O01U99NI)  
INGRCYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
INGRCYCLOMETHICONE 6 (UNII: XHK3U310BA)  
INGRPENTYLENE GLYCOL (UNII: 50C1307PZG)  
INGRRETINOL (UNII: G2SH0XKK91)  
INGREGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRSTEARETH-20 (UNII: L0Q8IK9E08)  
INGRCETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
INGRJOJOBA BUTTER (UNII: XIA46H803R)  
INGRVITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
INGRCURDLAN (UNII: 6930DL209R)  
INGRLACTOSE (UNII: J2B2A4N98G)  
INGRORANGE OIL (UNII: AKN3KSD11B)  
INGRMANDARIN OIL (UNII: NJO720F72R)  
INGRLEMON OIL (UNII: I9GRO824LL)  
INGRPEPPERMINT OIL (UNII: AV092KU4JH)  
INGRMIMOSA TENUIFLORA BARK (UNII: 515MQE449I)  
INGRARABIDOPSIS THALIANA (UNII: AI3L60HQ81)  
INGRC14-22 ALCOHOLS (UNII: B1K89384RJ)  
INGRCETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
INGRC12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
INGRPOWDERED CELLULOSE (UNII: SMD1X3XO9M)  
INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
INGRPALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)  
INGRPALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
INGRCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
INGRHYPROMELLOSES (UNII: 3NXW29V3WO)  
INGRHEXYLENE GLYCOL (UNII: KEH0A3F75J)  
INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGRLIMONENE, (+/-)- (UNII: 9MC3I34447)  
INGRULTRAMARINE BLUE (UNII: I39WR998BI)  
INGREXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
130 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
COSMETIC01/01/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/01/2012
Labeler - ZO Skin Health, Inc. (826468527)
Establishment
NameAddressID/FEIBusiness Operations
Owen Biosciences790003045MANUFACTURE(42851-155)
Establishment
NameAddressID/FEIBusiness Operations
PakLab, Inc.177711082MANUFACTURE(42851-155)

Revised: 4/2014
Document Id: f74e99ed-574f-46d5-bda5-c5cf16c674b5
Set id: 2d99bde7-2ecb-4609-80c4-739f08b9d1eb
Version: 1
Effective Time: 20140422
 
ZO Skin Health, Inc.