ROSACLEAR SKIN BALANCING SUN PROTECTION BROAD SPECTRUM 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.

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ROSACLEAR® SKIN BALANCING SUN PROTECTION BROAD SPECTRUM SPF 30
SUNSCREEN LOTION

Drug Facts

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

Uses

Warnings

For external use only

Do not use

  • on damaged or broken skin

Stop use 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

Inactive ingredients

alumina, butylparaben, C12-15 alkyl benzoate, cetearyl alcohol, coco-glucoside, dipropylene glycol, ethylparaben, glycerin, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, iron oxides, isobutylparaben, isohexadecane, isopropyl titanium triisostearate/triethoxycaprylylsilane crosspolymer, methylparaben, mica, PEG-6, phenoxyethanol, polyhydroxystearic acid, propylparaben, titanium dioxide, tocopheryl acetate, triethoxycaprylylsilane, water

Other information

Questions or comments?

1.800.636.7546
Monday-Friday 9 a.m.-4 p.m. Pacific Time

Except as otherwise indicated, all product names, slogans and other marks are trademarks of the Valeant family of companies.

Distributed by OMP, Inc., Long Beach, CA 90806

©2013 Obagi Medical Products, Inc., a division of Valeant Pharmaceuticals North America LLC.

www.obagi.com
Made in USA

10726414Z 7264
Rev. 12/13

PRINCIPAL DISPLAY PANEL - 85 g Bottle Label

OBAGI®
MEDICAL

rosaclear®

∙ NON-COMEDOGENIC ∙ NON-COMEDOGENIC

SKIN BALANCING
SUN PROTECTION

BROAD SPECTRUM SPF 30
SUNSCREEN LOTION

Net wt. 3 oz. (85 g)

Principal Display Panel - 85 g Bottle Label
ROSACLEAR SKIN BALANCING SUN PROTECTION BROAD SPECTRUM SPF 30   SUNCREEN
titanium dioxide and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62032-072
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:62032-072-6488 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(62032-072)

Revised: 10/2014
Document Id: affadfae-ce06-42b6-a044-ee621d6ea727
Set id: affadfae-ce06-42b6-a044-ee621d6ea727
Version: 1
Effective Time: 20141010
 
OMP, Inc.