NU-DERM SUN SHIELD SPF 50 SUNSCREEN- zinc oxide and octinoxate lotion

NU-DERM SUN SHIELD SPF 50 SUNSCREEN by

Drug Labeling and Warnings

NU-DERM SUN SHIELD SPF 50 SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by OMP, Inc., Milbar Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
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

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

NU-DERM SUN SHIELD SPF 50 SUNSCREEN 
zinc oxide and octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62032-124
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	105 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
WATER (UNII: 059QF0KO0R)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
PEG-40 STEARATE (UNII: ECU18C66Q7)
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TROPOLONE (UNII: 7L6DL16P1T)
CHLORPHENESIN (UNII: I670DAL4SZ)
XANTHAN GUM (UNII: TTV12P4NEE)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
UBIDECARENONE (UNII: EJ27X76M46)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
SQUALANE (UNII: GW89575KF9)
POLYSORBATE 60 (UNII: CAL22UVI4M)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62032-124-10	1 in 1 CARTON
1		89 mL in 1 TUBE

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

Labeler - OMP, Inc. (790553353)

Establishment
Name	Address	ID/FEI	Business Operations
Milbar Laboratories		195556790	MANUFACTURE(62032-124)