NU-DERM HEALTHY SKIN PROTECTION SPF 35- octinoxate and zinc oxide cream

NU-DERM HEALTHY SKIN PROTECTION by

Drug Labeling and Warnings

NU-DERM HEALTHY SKIN PROTECTION by is a Otc medication manufactured, distributed, or labeled by OBAGI COSMECEUTICAL LLC, Swiss-American CDMO, LLC. 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 9%	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
• 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
• children under 6 months: Ask a doctor

Other information

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

Inactive ingredients

butylparaben, cetearyl alcohol, citric acid, C13-14 isoparaffin, DEA-cetyl phosphate, disodium EDTA, ethylhexyl stearate, ethylparaben, isobutylparaben, isopropyl palmitate, laureth-7, methylparaben, phenoxyethanol, polyacrylamide, polyether-1, polysorbate 60, propylparaben, sodium hydroxide, triethoxycaprylylsilane, water (aqua)

Questions or comments?

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

SPL UNCLASSIFIED SECTION

Distributed by Obagi Cosmeceuticals LLC, Long Beach, CA 90806

PRINCIPAL DISPLAY PANEL - 85 g Bottle Label

RECOMMENDED
SKIN
CANCER
FOUNDATION
DAILY USE

The Skin Cancer Foundation
recommends this Product as an
effective UVA/UVB sunscreen

OBAGI
NU-DERM®

AM
HEALTHY SKIN
PROTECTION

BROAD SPECTRUM SPF 35

6
SUNSCREEN LOTION

Net wt. 3 oz. (85 g)

INGREDIENTS AND APPEARANCE

NU-DERM HEALTHY SKIN PROTECTION  SPF 35
octinoxate and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62032-200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	90 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYSORBATE 60 (UNII: CAL22UVI4M)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
METHYLPARABEN (UNII: A2I8C7HI9T)
LAURETH-7 (UNII: Z95S6G8201)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
DIETHANOLAMINE CETYL PHOSPHATE (UNII: 4UG0316V9S)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLPARABEN (UNII: 14255EXE39)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62032-200-90	90 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2002	03/31/2020
2	NDC: 62032-200-01	1 in 1 CARTON	04/01/2020
2		85 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/01/2002

Labeler - OBAGI COSMECEUTICAL LLC (790553353)

Establishment
Name	Address	ID/FEI	Business Operations
Swiss-American CDMO, LLC		080170933	MANUFACTURE(62032-200)