NU-DERM PHYSICAL UV BROAD SPECTRUM SPF 32- zinc oxide lotion

NU-DERM PHYSICAL UV by

Drug Labeling and Warnings

NU-DERM PHYSICAL UV by is a Otc medication manufactured, distributed, or labeled by Obagi Cosmeceuticals LLC, Swiss- American CDMO, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient	Purpose
Zinc Oxide 18.5%	Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

• For external use only
• Do not use on damaged or broken skin
• Stop use and ask a doctor if rash occurs
• When using this product keep out of eyes. Rinse with water to remove.
• Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• reapply at least every 2 hours
• children under 6 months: Ask a doctor
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m.-2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses

Inactive ingredients

beeswax, butylene glycol, cetyl dimethicone, cetyl PEG/PPG-10/1 dimethicone, dimethicone, disodium EDTA, epilobium angustifolium flower/leaf/stem extract, ethylhexyl stearate, glycereth-26, hydrogenated castor oil, isopropyl palmitate, methylparaben, propylparaben, sodium chloride, tocopherol acetate, triethoxycaprylylsilane, water

Other information

• store at controlled room temperature: 15°C-25°C (59°F-77°F)
• protect this product from excessive heat and direct sun

Questions or comments?

1.800.636.7546
Monday-Friday 9 a.m.-4 p.m. Pacific Time

SPL UNCLASSIFIED SECTION

Obagi Nu-Derm is a registered trademark of OMP, Inc.

Distributed by OMP, Inc., Long Beach, CA 90806

©2012 Obagi Medical Products, Inc. All rights reserved.

www.obagi.com
Made in USA

10701810Z 7018

PRINCIPAL DISPLAY PANEL - 57 g Bottle Label

OBAGI
NU-DERM®

AM
PHYSICAL
UV
BROAD SPECTRUM
SPF 32

6

Zinc Oxide 18.5%

SUNSCREEN LOTION

Net wt. 2 oz. (57 g)

INGREDIENTS AND APPEARANCE

NU-DERM PHYSICAL UV  BROAD SPECTRUM SPF 32
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62032-070
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	185 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
YELLOW WAX (UNII: 2ZA36H0S2V)
GLYCERETH-26 (UNII: NNE56F2N14)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
METHYLPARABEN (UNII: A2I8C7HI9T)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
EDETATE DISODIUM (UNII: 7FLD91C86K)
EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62032-070-18	57 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2004

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/01/2004

Labeler - Obagi Cosmeceuticals LLC (790553353)

Establishment
Name	Address	ID/FEI	Business Operations
Swiss- American CDMO, LLC		080170933	MANUFACTURE(62032-070)