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Name:Nu-derm Sun Shield Spf 50 Sunscreen
Manufacturer:Obagi Medical Products, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Nu-Derm Sun Shield SPF 50

NU-DERM SUN SHIELD SPF 50 SUNSCREEN - octinoxate and zinc oxide lotion 
Obagi Medical Products, 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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Nu-Derm Sun Shield SPF 50

Drug Facts

Active Ingredients

Octinoxate 7.5%

Zinc Oxide 10.5%

Purpose

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: 15ºC - 30ºC (59ºF - 86ºF).
  • 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 Acryloyldimethyl 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

PRINCIPAL DISPLAY PANEL

OBAGI MEDICAL
Nu-Derm® Sun Shield SPF 50
Sunscreen Lotion
High UVA/PA +++
UVB
NON-COMEDOGENIC
DERMATOLOGIST TESTED
3 fl. oz. (89 mL)

PRINCIPAL DISPLAY PANEL
OBAGI MEDICAL
Nu-Derm® Sun Shield SPF 50
3 fl. oz. (89 mL)


NU-DERM SUN SHIELD SPF 50 SUNSCREEN 
octinoxate and zinc oxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:62032-124
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 0.075 mL  in 1 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 0.105 mL  in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
CYCLOMETHICONE 5  
SQUALANE  
CITRIC ACID  
POLYSORBATE 60  
CAPRYLYL GLYCOL  
SODIUM BENZOATE  
TROPOLONE  
EDETATE DISODIUM  
METHYLISOTHIAZOLINONE  
DIMETHICONE  
PENTYLENE GLYCOL  
STEARYL ALCOHOL  
PHENYL TRIMETHICONE  
PEG-40 STEARATE  
POLYOXYL 20 CETOSTEARYL ETHER  
CHLORPHENESIN  
CETOSTEARYL ALCOHOL  
XANTHAN GUM  
1,2-HEXANEDIOL  
POTASSIUM SORBATE  
TETRAHEXYLDECYL ASCORBATE  
Product Characteristics
Color WHITE Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62032-124-10 1 TUBE (1 TUBE) in 1 CARTON contains a TUBE
1 89 mL in 1 TUBE This package is contained within the CARTON (62032-124-10)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part352 01/05/2011

Labeler - Obagi Medical Products, Inc. (790553353)
Establishment
Name Address ID/FEI Operations
Milbar Laboratories 055359970 MANUFACTURE

Revised: 03/2011 Obagi Medical Products, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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