CONDITION AND ENHANCE HEALTHY SKIN PROTECTION SPF 35- octinoxate and zinc oxide cream 
OMP, 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.

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CONDITION & ENHANCE
HEALTHY SKIN
PROTECTION
SPF 35

Drug Facts

Active Ingredients

Octinoxate, 7.5%, Zinc Oxide, 9%

Purpose

Sunscreens

Uses

Warnings

When using this product

  • Keep out of eyes. Rinse with water to remove.

Stop use and ask a physician if

  • Rash or irritation develops and lasts.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Other Information

Inactive Ingredients

Butylparaben, cetearyl alcohol, citric acid, C13-14 isoparaffin, diethanolamine cetyl phosphate, disodium edetate, ethylparaben, isobutylparaben, isopropyl palmitate, laureth-7, methylparaben, octyl stearate, phenoxyethanol, polyacrylamide, polyether-1, polysorbate 60, propylparaben, purified water, sodium hydroxide, triethoxycaprylysilane.

Dist. by OMP Inc. Long Beach, CA 90802

PRINCIPAL DISPLAY PANEL - 90 mL Bottle Label

OBAGI®
MEDICAL

CONDITION & ENHANCE

AM 6

healthy skin
protection
SPF 35

Broad-Spectrum
UVA/UVB Sunscreen

RECOMMENDED
SKIN
CANCER
FOUNDATION

3 FL. OZ. (90 mL)

Principal Display Panel - 90 mL Bottle Label
CONDITION AND ENHANCE HEALTHY SKIN PROTECTION  SPF 35
octinoxate and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62032-119
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE90 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
WATER (UNII: 059QF0KO0R)  
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
LAURETH-7 (UNII: Z95S6G8201)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
DIETHANOLAMINE CETYL PHOSPHATE (UNII: 4UG0316V9S)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLPARABEN (UNII: 14255EXE39)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62032-119-1030 mL in 1 BOTTLE, PLASTIC
2NDC:62032-119-9090 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/01/2002
Labeler - OMP, Inc. (790553353)
Establishment
NameAddressID/FEIBusiness Operations
Swiss-American Products611921669MANUFACTURE(62032-119)

Revised: 12/2011
Document Id: d849a01a-d751-4bd9-b02a-082968689a93
Set id: 5d576a6d-7b7a-468d-bc32-f453583fd3cf
Version: 1
Effective Time: 20111215
 
OMP, Inc.