ROSACLEAR SKIN BALANCING SUN PROTECTION SPF 30 SUNCREEN

Dosage form: lotion
Ingredients: TITANIUM DIOXIDE 20mg in 1mL, ZINC OXIDE 155mg in 1mL
Labeler: OMP, Inc.
NDC Code: 62032-103

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
  • helps prevent sunburn
  • higher SPF gives more sunburn protection.

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
  • apply liberally before sun exposure and as needed.
  • children under 6 months of age: ask a doctor.
  • reapply as needed or after towel drying, swimming, or sweating.

Other information
  • store at controlled room temperature: 15-25°C (59-77°F).
  • Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer and other harmful effects of the sun.

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)

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 AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE20 mg  in 1 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE155 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALKYL (C12-15) BENZOATE 
WATER 
POLYHYDROXYSTEARIC ACID (2300 MW) 
DIPROPYLENE GLYCOL 
POLYETHYLENE GLYCOL 300 
CETOSTEARYL ALCOHOL 
COCO GLUCOSIDE 
METHYLPARABEN 
ALUMINUM OXIDE 
PROPYLPARABEN 
ISOHEXADECANE 
MICA 
FERRIC OXIDE RED 
FERROSOFERRIC OXIDE 
ALPHA-TOCOPHEROL ACETATE 
TRIETHOXYCAPRYLYLSILANE 
ETHYLPARABEN 
ISOBUTYLPARABEN 
BUTYLPARABEN 
PHENOXYETHANOL 
GLYCERIN 
FERRIC OXIDE YELLOW 
Product Characteristics
ColorGRAYScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
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/FEIOperations
Swiss-American Products611921669MANUFACTURE(62032-103)

Revised: 12/2011
 
OMP, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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