NU-DERM HEALTHY SKIN PROTECTION

Manufacturer: Obagi Cosmeceuticals LLC | Swiss-American CDMO, LLC
Effective date: 2025-01-01
Label type: HUMAN OTC DRUG LABEL
Version: 7
Source: full-release
Hydrated at: 2026-06-01 00:57:13

Label at a glance#

ProductNU-DERM HEALTHY SKIN PROTECTION SPF 35

Active ingredientOCTINOXATE, ZINC OXIDE

Label structure10 sections

Indications and 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

Dosage and administration

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 ...

Storage and handling

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

Contacts and useful links#

PhoneLabel contact1.800.636.7546

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients	Purpose
Octinoxate 7.5%	Sunscreen
Zinc Oxide 9%	Sunscreen

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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)

PRINCIPAL DISPLAY PANEL - 85 g Bottle Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
62032-200-01	2025-03-14	C162847	48780-1	2cef2736-831e-d83d-e063-dadaa90ab31f	NU-DERM HEALTHY SKIN PROTECTION SPF 35
62032-200-90	2025-03-14	C162847	48780-1	2cef2736-831e-d83d-e063-dadaa90ab31f	NU-DERM HEALTHY SKIN PROTECTION SPF 35
62032-200-01	2025-01-30	C162847	48780-1	2cef2736-831e-d83d-e063-dadaa90ab31f	NU-DERM HEALTHY SKIN PROTECTION SPF 35
62032-200-90	2025-01-30	C162847	48780-1	2cef2736-831e-d83d-e063-dadaa90ab31f	NU-DERM HEALTHY SKIN PROTECTION SPF 35

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
62032-200-01	NU-DERM HEALTHY SKIN PROTECTIONSPF 35	1 in 1 CARTON	CREAM	1	7
62032-200-01	NU-DERM HEALTHY SKIN PROTECTIONSPF 35	85 mL in 1 BOTTLE, PLASTIC	CREAM	85	7
62032-200-90	NU-DERM HEALTHY SKIN PROTECTIONSPF 35	90 mL in 1 BOTTLE, PLASTIC	CREAM	90	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62032-200	NU-DERM HEALTHY SKIN PROTECTION SPF 35 (OCTINOXATE AND ZINC OXIDE) CREAM [OBAGI COSMECEUTICALS LLC]	7	Current NDC, Legacy NDC, 3 package rows	20250316_cfb6a918-1403-4cf2-86d8-d66dd764bb6c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	2
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	2
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	2
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	2
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	2
C13-14 ISOPARAFFIN	INACTIVE INGREDIENT	E4F12ROE70	2
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	2
DIETHANOLAMINE CETYL PHOSPHATE	INACTIVE INGREDIENT	4UG0316V9S	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	2
ETHYLHEXYL STEARATE	INACTIVE INGREDIENT	EG3PA2K3K5	2
ETHYLPARABEN	INACTIVE INGREDIENT	14255EXE39	2
ISOBUTYLPARABEN	INACTIVE INGREDIENT	0QQJ25X58G	2
ISOPROPYL PALMITATE	INACTIVE INGREDIENT	8CRQ2TH63M	2
LAURETH-7	INACTIVE INGREDIENT	Z95S6G8201	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	2
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	2
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	2
TRIETHOXYCAPRYLYLSILANE	INACTIVE INGREDIENT	LDC331P08E	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 22 matching rows.

NU-DERM HEALTHY SKIN PROTECTION SPF 35
OCTINOXATE and ZINC OXIDE
OCTINOXATE
ZINC OXIDE
ISOPROPYL PALMITATE
WATER
ETHYLHEXYL STEARATE
CETOSTEARYL ALCOHOL
POLYSORBATE 60
C13-14 ISOPARAFFIN
METHYLPARABEN
LAURETH-7
PROPYLPARABEN
EDETATE DISODIUM
BUTYLPARABEN
DIETHANOLAMINE CETYL PHOSPHATE
PHENOXYETHANOL
ETHYLPARABEN
ISOBUTYLPARABEN
SODIUM HYDROXIDE
TRIETHOXYCAPRYLYLSILANE
CITRIC ACID MONOHYDRATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
62032-200	62032-200-01, 62032-200-90

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
OCTINOXATE	4Y5P7MUD51	ACTIB
ZINC OXIDE	SOI2LOH54Z	ACTIB
ISOPROPYL PALMITATE	8CRQ2TH63M	IACT
WATER	059QF0KO0R	IACT
ETHYLHEXYL STEARATE	EG3PA2K3K5	IACT
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
POLYSORBATE 60	CAL22UVI4M	IACT
C13-14 ISOPARAFFIN	E4F12ROE70	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
LAURETH-7	Z95S6G8201	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
BUTYLPARABEN	3QPI1U3FV8	IACT
DIETHANOLAMINE CETYL PHOSPHATE	4UG0316V9S	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
ETHYLPARABEN	14255EXE39	IACT
ISOBUTYLPARABEN	0QQJ25X58G	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
TRIETHOXYCAPRYLYLSILANE	LDC331P08E	IACT
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 42 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
ISOPROPYL PALMITATE	ISOPROPYL PALMITATE	8CRQ2TH63M	CREAM / TOPICAL		112 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CREAM / TOPICAL		3000 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	CREAM / TOPICAL		57 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CREAM / TOPICAL		6 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	CREAM / TOPICAL	0.4 %w/w		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	CREAM / TOPICAL		4 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
ETHYLPARABEN	ETHYLPARABEN	14255EXE39	GRANULE, FOR SOLUTION / ORAL		14 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	CREAM / TOPICAL		69 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	CREAM / TOPICAL		4 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
ISOPROPYL PALMITATE	ISOPROPYL PALMITATE	8CRQ2TH63M	CREAM / TOPICAL		112 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CREAM / TOPICAL		3000 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
ETHYLPARABEN	ETHYLPARABEN	14255EXE39	SOLUTION / ORAL		14 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
ETHYLPARABEN	ETHYLPARABEN	14255EXE39	GRANULE, FOR SOLUTION / ORAL		14 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
ISOPROPYL PALMITATE	ISOPROPYL PALMITATE	8CRQ2TH63M	CREAM / TOPICAL		112 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CREAM / TOPICAL		3000 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	CREAM / TOPICAL		225 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
ETHYLPARABEN	ETHYLPARABEN	14255EXE39	SOLUTION / ORAL		14 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
ETHYLPARABEN	ETHYLPARABEN	14255EXE39	SUSPENSION / ORAL		8 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
ETHYLPARABEN	ETHYLPARABEN	14255EXE39	GRANULE, FOR SOLUTION / ORAL		14 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
ETHYLPARABEN	ETHYLPARABEN	14255EXE39	POWDER, FOR SOLUTION / ORAL		13 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CREAM / TOPICAL		6 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
ETHYLPARABEN	ETHYLPARABEN	14255EXE39	SUSPENSION / ORAL		8 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	CREAM / TOPICAL		1428 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	CREAM / TOPICAL		225 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	CREAM / TOPICAL		1428 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	CREAM / TOPICAL		1428 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
ETHYLPARABEN	ETHYLPARABEN	14255EXE39	SOLUTION / ORAL		14 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	CREAM / TOPICAL		57 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	CREAM / TOPICAL		225 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CREAM / TOPICAL		6 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	CREAM / TOPICAL		57 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CREAM / TOPICAL		14 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	CREAM / TOPICAL		69 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	CREAM / TOPICAL		4 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
ETHYLPARABEN	ETHYLPARABEN	14255EXE39	POWDER, FOR SOLUTION / ORAL		13 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CREAM / TOPICAL		14 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
ETHYLPARABEN	ETHYLPARABEN	14255EXE39	POWDER, FOR SOLUTION / ORAL		13 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	CREAM / TOPICAL	0.4 %w/w		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
ETHYLPARABEN	ETHYLPARABEN	14255EXE39	SUSPENSION / ORAL		8 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	CREAM / TOPICAL		69 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CREAM / TOPICAL		14 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	CREAM / TOPICAL	0.4 %w/w		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NU-DERM HEALTHY SKIN PROTECTION SPF 35	OCTINOXATE AND ZINC OXIDE	Obagi Cosmeceuticals LLC	cfb6a918-1403-4cf2-86d8-d66dd764bb6c	2025-01-01	Warnings	Exact identifier ndc (package): 62032-200-90 ndc (package): 62032-200-01 ndc (product): 62032-200 ndc11 (package): 62032020090 ndc11 (package): 62032020001 spl id: c8e9655e-6ce4-4a41-a31d-896bfde6f0af spl set id: cfb6a918-1403-4cf2-86d8-d66dd764bb6c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.