ROSACLEAR SKIN BALANCING SUN PROTECTION SPF 30  SUNCREEN- titanium dioxide and zinc oxide lotion 
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.

----------

ROSACLEAR® SKIN BALANCING SUN PROTECTION SPF 30
SUNSCREEN LOTION

Drug Facts

Active ingredientsPurpose
Titanium Dioxide 2.0%Sunscreen
Zinc Oxide 15.5%Sunscreen

Uses

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

Other information

Inactive ingredients

Alumina, Butylparaben, Cetearyl Alcohol, Coco-Glucoside, C12-15 Alkyl Benzoate, Dipropylene Glycol, PEG-6, Ethylparaben, Glycerin, Hydroxyethyl Acrylate/ Sodium Acryloyldimethyl Taurate Copolymer, Iron Oxides, Isobutylparaben, Isohexadecane, Isopropyl Titanium Triisostearate/Triethoxycaprylylsilane Crosspolymer, Methylparaben, Mica, Phenoxyethanol, Polyhydroxystearic Acid, Propylparaben,Tocopheryl Acetate, Triethoxycaprylylsilane, Water.

Dist. by OMP, Inc.
3760 Kilroy Airport Way Suite 500
Long Beach, CA 90806

PRINCIPAL DISPLAY PANEL - 88 mL Bottle Label

OBAGI®
MEDICAL

rosaclear®
system

∙ NON-COMEDOGENIC ∙ NON-COMEDOGENIC

SKIN BALANCING
SUN PROTECTION

SPF 30
SUNSCREEN LOTION

3 FL.OZ. (88 mL)

Principal Display Panel - 88 mL Bottle Label
ROSACLEAR SKIN BALANCING SUN PROTECTION SPF 30   SUNCREEN
titanium dioxide and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62032-103
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE20 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE155 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
WATER (UNII: 059QF0KO0R)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
COCO GLUCOSIDE (UNII: ICS790225B)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ETHYLPARABEN (UNII: 14255EXE39)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
GLYCERIN (UNII: PDC6A3C0OX)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
Product Characteristics
ColorGRAYScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62032-103-9088 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/01/2009
Labeler - OMP, Inc. (790553353)
Establishment
NameAddressID/FEIBusiness Operations
Swiss-American Products611921669MANUFACTURE(62032-103)

Revised: 12/2011
Document Id: f05364b7-1473-4cf3-81d7-3e2b031d545e
Set id: 8017e35e-ddf7-4d57-84b4-7e591448095e
Version: 1
Effective Time: 20111230
 
OMP, Inc.