NU-DERM PHYSICAL UV BLOCK SPF 32- zinc oxide cream

NU-DERM PHYSICAL UV BLOCK by

Drug Labeling and Warnings

NU-DERM PHYSICAL UV BLOCK by is a Otc medication manufactured, distributed, or labeled by OMP, Inc., Swiss-American Products. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Zinc oxide 18.5%.

WARNINGS

FOR EXTERNAL USE ONLY. Avoid contact with eyes. If this occurs, rinse with water.

STOP USE

Stop use and contact a doctor if rash or irritation develops.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

DIRECTIONS

Apply liberally to all exposed areas 15 minutes prior to sun exposure and as needed. For children less than 6 months of age, consult a doctor.

STORAGE AND HANDLING

Store at controlled room temperature:
15°-30°C (59°-86°F)

INACTIVE INGREDIENTS

bees wax, butylene glycol, cetyl dimethicone, cetyl PEG/PPG-10/1 dimethicone, dimethicone, disodium EDTA, glycereth-26, hydrogenated castor oil, isopropyl palmitate, methylparaben, octyl stearate, propylparaben, purified water, sodium chloride, triethoxycaprylylsilane, tocopherol acetate, willowherb extract

SPL UNCLASSIFIED SECTION

Dist. by OMP Inc. Long Beach, CA 90802

PRINCIPAL DISPLAY PANEL - 57g Bottle Label

OBAGI
NU-DERM®

AM
PHYSICAL
UV BLOCK
SPF 32

6

BROAD SPECTRUM UVA/UVB
PHYSICAL SUNBLOCK

18.5% ZINC OXIDE

NET WT. 2 OZ. (57g)

INGREDIENTS AND APPEARANCE

NU-DERM PHYSICAL UV BLOCK   SPF 32
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62032-102
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: 62032-102-36	57 g in 1 BOTTLE, PLASTIC

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

Labeler - OMP, Inc. (790553353)

Establishment
Name	Address	ID/FEI	Business Operations
Swiss-American Products		611921669	MANUFACTURE(62032-102)