NU-DERM HEALTHY SKIN PROTECTION SPF 35

Dosage form: cream
Ingredients: OCTINOXATE 75mg in 1mL, ZINC OXIDE 90mg in 1mL
Labeler: OMP, Inc.
NDC Code: 62032-200

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.

NU-DERM ®
HEALTHY SKIN
PROTECTION
SPF 35

Drug Facts

Active ingredients

Octinoxate, 7.5%, Zinc oxide, 9%

Purpose

Sunscreens

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 the reach of children.

  • If swallowed, get medical help or contact a Poison Control Center right away.

Directions
  • Apply generously and evenly 15 minutes before sun exposure.
  • Children under six months of age: ask a doctor.
  • Reapply as needed or after towel drying, swimming or perspiring.

Other information
  • Store at controlled room temperature: 15°-30°C (59°-86°F).
  • High sun protection product.
  • 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

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

THE SKIN CANCER FOUNDATION
RECOMMENDED

The Skin Cancer Foundation
recommends this Product as
an effective UV sunscreen

OBAGI
NU-DERM
®

AM

HEALTHY SKIN
PROTECTION
SPF 35

6

BROAD-SPECTRUM
UVA/UVB SUNSCREEN

3 FL.OZ. (90 mL)

NU-DERM HEALTHY SKIN PROTECTION   SPF 35
octinoxate and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62032-200
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE75 mg  in 1 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE90 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL PALMITATE 
WATER 
ETHYLHEXYL STEARATE 
CETOSTEARYL ALCOHOL 
POLYSORBATE 60 
C13-14 ISOPARAFFIN 
METHYLPARABEN 
LAURETH-7 
PROPYLPARABEN 
EDETATE DISODIUM 
BUTYLPARABEN 
DIETHANOLAMINE CETYL PHOSPHATE 
PHENOXYETHANOL 
ETHYLPARABEN 
ISOBUTYLPARABEN 
SODIUM HYDROXIDE 
TRIETHOXYCAPRYLYLSILANE 
CITRIC ACID MONOHYDRATE 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:62032-200-1030 mL in 1 BOTTLE, PLASTIC
2NDC:62032-200-9090 mL in 1 BOTTLE, PLASTIC
3NDC:62032-200-086 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/01/2002
Labeler - OMP, Inc. (790553353)
Establishment
NameAddressID/FEIOperations
Swiss-American Products611921669MANUFACTURE(62032-200)

Revised: 07/2013
 
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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