NU-DERM SUN SHIELD SPF 50 SUNSCREEN

Dosage form: lotion
Ingredients: ZINC OXIDE 105mg in 1mL, OCTINOXATE 75mg in 1mL
Labeler: OMP, Inc.
NDC Code: 62032-124

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®
SUN SHIELD
SPF 50

Drug Facts

Active IngredientsPurpose
Octinoxate 7.5%Sunscreen
Zinc Oxide 10.5%Sunscreen

Uses
  • helps prevent sunburn
  • higher SPF provides more sunburn protection
  • provides high protection against sunburn

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 30 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • Reapply as needed or after towel drying, swimming, or perspiring.

Other Information
  • Store at controlled room temperature:
    15°C-30° (59°F-86°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

Water, Cyclopentasiloxane, PEG-10 Dimethicone, Pentylene Glycol, Stearyl Alcohol, Phenyl Trimethicone, PEG-40 Stearate, Hydroxyethyl Acrylate/Sodium Acryloydimethyl Taurate Copolymer, Sodium Dihydroxycetyl Phosphate, Citric Acid, Squalane, Ceteareth-20, Polysilicone-11, Dimethicone Crosspolymer-3, Chlorphenesin, Cetearyl Alcohol, Ethoxylated Sorbitan Ester, Xanthan Gum, 1,2-Hexanediol, Caprylyl Glycol, Potassium Sorbate, Sodium Benzoate, Polysorbate 60, Tetrahexyldecyl Ascorbate, Disodium EDTA, Methylisothiazolinone, Hydrogenated Palm Glycerides, Ubiquinone, Tropolone.

Questions?

1.800.636.7546

Monday–Friday 9:00 AM–4:00 PM Pacific Time

Distributed by OMP, Inc.

PRINCIPAL DISPLAY PANEL - 89 mL Tube Carton

OBAGI®
MEDICAL

Nu-Derm®

Sun Shield
SPF 50

Sunscreen Lotion
High UVA/PA+++
UVB

6
AM

NON-COMEDOGENIC
DERMATOLOGIST TESTED

3 fl. oz. (89 mL)

NU-DERM SUN SHIELD SPF 50 SUNSCREEN 
zinc oxide and octinoxate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62032-124
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE105 mg  in 1 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE75 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 5 
WATER 
PEG-10 DIMETHICONE (600 CST) 
PENTYLENE GLYCOL 
STEARYL ALCOHOL 
POLYOXYL 20 CETOSTEARYL ETHER 
PHENYL TRIMETHICONE 
PEG-40 STEARATE 
HYDROGENATED PALM GLYCERIDES 
CITRIC ACID MONOHYDRATE 
CETOSTEARYL ALCOHOL 
1,2-HEXANEDIOL 
CAPRYLYL GLYCOL 
TROPOLONE 
CHLORPHENESIN 
XANTHAN GUM 
POTASSIUM SORBATE 
SODIUM BENZOATE 
TETRAHEXYLDECYL ASCORBATE 
UBIDECARENONE 
EDETATE DISODIUM 
METHYLISOTHIAZOLINONE 
SQUALANE 
POLYSORBATE 60 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:62032-124-101 TUBE (TUBE) in 1 CARTON
189 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/05/2011
Labeler - OMP, Inc. (790553353)
Establishment
NameAddressID/FEIOperations
Milbar Laboratories195556790MANUFACTURE(62032-124)

Revised: 01/2012
 
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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