TheradermSPF 43

Manufacturer: Therapon Skin Health, LP | Swiss American Products, Inc.
Effective date: 2012-01-20
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:30:43

Label at a glance#

ProductTheradermSPF 43 SPF 43

Active ingredientZinc Oxide, Octinoxate, Octisalate

Label structure6 sections

Indications and uses

Helps prevent sunburn and photo damage caused by UVA/UVB exposure.

Dosage and administration

Apply generously 15 minutes before sun exposure. Reapply to dry skin as needed. May be applied before make-up Best used within 12 months of opening.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 7.50% ...................Sunscreen
Octinoxate 7.50% ...................Sunscreen
Octisalate 2.50% ...................Sunscreen

Uses

OTC - PURPOSE SECTION

Helps prevent sunburn and photo damage caused by UVA/UVB exposure.

Warnings

WARNINGS SECTION

For External use only.
When using, avoid contact with eyes. If contact occurs, rinse thoroughly with water.
Stop use and contact a doctor if irritation or rash develops.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply generously 15 minutes before sun exposure.
Reapply to dry skin as needed.
May be applied before make-up

Best used within 12 months of opening.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified water, Isopropyl palmitate, Octyl stearate, Ethyl hexyl isononanoate,Cyclopentasiloxane, Cetearyl glucoside, Dimethicone, Glycereth-26, Sodium Hyaluronate, Panthenol, Allantoin, Oleth-3 phosphate, Hydroxyethyl Acrylate/Sodium acryloyl dimethyl taurate copolymer, Polyisobutene, PEG-7 trimethylolpropane coconut ether, Polyether-1, Phenoxyethanol, Butylene glycol, Iodopropynyl butylcarbamate, Tocopheryl acetate, Triethoxycaprylylsilane.

Label for Tube and Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Theraderm Tube LabelLabel

Theraderm Box LabelBox

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
66428-002-02	2019-11-13	C162847	48780-1	97449f38-c083-f6ea-e053-dbdaa90aa703	Theraderm

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66428-002-02	TheradermSPF 43 SPF 43	1 in 1 BOX	EMULSION	1		2
66428-002-02	TheradermSPF 43 SPF 43	90 mL in 1 TUBE	EMULSION	90		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66428-002	THERADERMSPF 43 SPF 43 (ZINC OXIDE, OCTINOXATE, OCTISALATE) EMULSION [THERAPON SKIN HEALTH, LP]	2	Legacy NDC, 2 package rows	20120124_d83f0f88-8112-47dc-9bc5-c56f86dec51a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Octinoxate	ACTIVE INGREDIENT	4Y5P7MUD51	2
Octisalate	ACTIVE INGREDIENT	4X49Y0596W	2
Zinc Oxide	ACTIVE INGREDIENT	SOI2LOH54Z	2
Octinoxate	ACTIVE MOIETY	4Y5P7MUD51	2
Octisalate	ACTIVE MOIETY	4X49Y0596W	2
Zinc Oxide	ACTIVE MOIETY	SOI2LOH54Z	2
.Alpha.-Tocopherol Acetate	INACTIVE INGREDIENT	9E8X80D2L0	2
2-Hydroxyethyl Acrylate	INACTIVE INGREDIENT	25GT92NY0C	2
Allantoin	INACTIVE INGREDIENT	344S277G0Z	2
Ascorbyl Palmitate	INACTIVE INGREDIENT	QN83US2B0N	2
Butylene Glycol	INACTIVE INGREDIENT	3XUS85K0RA	2
Cetearyl Glucoside	INACTIVE INGREDIENT	09FUA47KNA	2
Coconut Alcohol	INACTIVE INGREDIENT	13F4MW8Y9K	2
Cyclomethicone 5	INACTIVE INGREDIENT	0THT5PCI0R	2
Dimethicone	INACTIVE INGREDIENT	92RU3N3Y1O	2
Ethylene Oxide	INACTIVE INGREDIENT	JJH7GNN18P	2
Ethylhexyl Isononanoate	INACTIVE INGREDIENT	I6KB4GE3K4	2
Glycereth-26	INACTIVE INGREDIENT	NNE56F2N14	2
Hyaluronate Sodium	INACTIVE INGREDIENT	YSE9PPT4TH	2
Iodopropynyl Butylcarbamate	INACTIVE INGREDIENT	603P14DHEB	2
Isopropyl Palmitate	INACTIVE INGREDIENT	8CRQ2TH63M	2
Octyl Stearate	INACTIVE INGREDIENT	772Y4UFC8B	2
Oleth-3 Phosphate	INACTIVE INGREDIENT	8Q0Z18J1VL	2
Panthenol	INACTIVE INGREDIENT	WV9CM0O67Z	2
Phenoxyethanol	INACTIVE INGREDIENT	HIE492ZZ3T	2
Polyester-7	INACTIVE INGREDIENT	0841698D2F	2
Polyethylene Glycol 350	INACTIVE INGREDIENT	ZBR3T82M2V	2
Polyisobutylene (1300 MW)	INACTIVE INGREDIENT	241BN7J12Y	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 · 29 matching rows.

TheradermSPF 43 SPF 43
Zinc Oxide, Octinoxate, Octisalate
Zinc Oxide
Octinoxate
Octisalate
Water
Isopropyl Palmitate
Octyl Stearate
Ethylhexyl Isononanoate
Cyclomethicone 5
Cetearyl Glucoside
Dimethicone
Glycereth-26
Hyaluronate Sodium
Panthenol
Allantoin
Oleth-3 Phosphate
2-Hydroxyethyl Acrylate
Polyisobutylene (1300 MW)
Coconut Alcohol
Polyester-7
Ethylene Oxide
Polyethylene Glycol 350
Phenoxyethanol
Butylene Glycol
Iodopropynyl Butylcarbamate
.Alpha.-Tocopherol Acetate
Ascorbyl Palmitate
Triethoxycaprylylsilane

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
66428-002	66428-002-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Zinc Oxide	SOI2LOH54Z	ACTIB
Octinoxate	4Y5P7MUD51	ACTIB
Octisalate	4X49Y0596W	ACTIB
Water	059QF0KO0R	IACT
Isopropyl Palmitate	8CRQ2TH63M	IACT
Octyl Stearate	772Y4UFC8B	IACT
Ethylhexyl Isononanoate	I6KB4GE3K4	IACT
Cyclomethicone 5	0THT5PCI0R	IACT
Cetearyl Glucoside	09FUA47KNA	IACT
Dimethicone	92RU3N3Y1O	IACT
Glycereth-26	NNE56F2N14	IACT
Hyaluronate Sodium	YSE9PPT4TH	IACT
Panthenol	WV9CM0O67Z	IACT
Allantoin	344S277G0Z	IACT
Oleth-3 Phosphate	8Q0Z18J1VL	IACT
2-Hydroxyethyl Acrylate	25GT92NY0C	IACT
Polyisobutylene (1300 MW)	241BN7J12Y	IACT
Coconut Alcohol	13F4MW8Y9K	IACT
Polyester-7	0841698D2F	IACT
Ethylene Oxide	JJH7GNN18P	IACT
Polyethylene Glycol 350	ZBR3T82M2V	IACT
Polyisobutylene (1300 MW)	241BN7J12Y	IACT
Phenoxyethanol	HIE492ZZ3T	IACT
Butylene Glycol	3XUS85K0RA	IACT
Iodopropynyl Butylcarbamate	603P14DHEB	IACT
.Alpha.-Tocopherol Acetate	9E8X80D2L0	IACT
Ascorbyl Palmitate	QN83US2B0N	IACT
Triethoxycaprylylsilane	LDC331P08E	IACT

Source Document#

Source XML

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 · 35 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Ascorbyl Palmitate	ASCORBYL PALMITATE	QN83US2B0N	TABLET / ORAL	7.14 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
Isopropyl Palmitate	ISOPROPYL PALMITATE	8CRQ2TH63M	GEL / TOPICAL	NA		Exact identifier — unii candidate 8 equally ranked IID candidates
Ascorbyl Palmitate	ASCORBYL PALMITATE	QN83US2B0N	CAPSULE / ORAL	12 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
.Alpha.-Tocopherol Acetate	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	TABLET / ORAL	0.5 mg		Exact identifier — unii candidate 3 equally ranked IID candidates
Phenoxyethanol	PHENOXYETHANOL	HIE492ZZ3T	CREAM / TOPICAL		57 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
Butylene Glycol	BUTYLENE GLYCOL	3XUS85K0RA	SYSTEM / TRANSDERMAL	8.12 mg		Exact identifier — unii candidate 2 equally ranked IID candidates
Phenoxyethanol	PHENOXYETHANOL	HIE492ZZ3T	AEROSOL / TOPICAL	1.05 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
Phenoxyethanol	PHENOXYETHANOL	HIE492ZZ3T	LOTION / TOPICAL	1 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
Isopropyl Palmitate	ISOPROPYL PALMITATE	8CRQ2TH63M	FILM, EXTENDED RELEASE / TRANSDERMAL	187.5 mg		Exact identifier — unii candidate 8 equally ranked IID candidates
Hyaluronate Sodium	HYALURONATE SODIUM	YSE9PPT4TH	INJECTION, SUSPENSION / INTRAVITREAL		23 mg	Exact identifier — unii candidate 5 equally ranked IID candidates
Phenoxyethanol	PHENOXYETHANOL	HIE492ZZ3T	AEROSOL, FOAM / TOPICAL		72 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
Isopropyl Palmitate	ISOPROPYL PALMITATE	8CRQ2TH63M	FILM / TRANSDERMAL		2 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
Ascorbyl Palmitate	ASCORBYL PALMITATE	QN83US2B0N	SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 6 equally ranked IID candidates
.Alpha.-Tocopherol Acetate	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	FILM / BUCCAL	0.09 mg		Exact identifier — unii candidate 3 equally ranked IID candidates
Hyaluronate Sodium	HYALURONATE SODIUM	YSE9PPT4TH	LOTION / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 5 equally ranked IID candidates
Hyaluronate Sodium	HYALURONATE SODIUM	YSE9PPT4TH	INJECTION, SUSPENSION / INTRA-ARTICULAR		23 mg	Exact identifier — unii candidate 5 equally ranked IID candidates
Cyclomethicone 5	CYCLOMETHICONE 5	0THT5PCI0R	CREAM, AUGMENTED / TOPICAL		260 mg	Exact identifier — unii candidate 3 equally ranked IID candidates
Isopropyl Palmitate	ISOPROPYL PALMITATE	8CRQ2TH63M	AEROSOL, SPRAY / TOPICAL		397 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
Isopropyl Palmitate	ISOPROPYL PALMITATE	8CRQ2TH63M	AEROSOL / TOPICAL		397 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
Ascorbyl Palmitate	ASCORBYL PALMITATE	QN83US2B0N	CREAM / TOPICAL	0.02 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
Cyclomethicone 5	CYCLOMETHICONE 5	0THT5PCI0R	AEROSOL / TOPICAL	2.5 %w/w		Exact identifier — unii candidate 3 equally ranked IID candidates
Allantoin	ALLANTOIN	344S277G0Z	GEL / TOPICAL		8 mg	Exact identifier — unii candidate
Isopropyl Palmitate	ISOPROPYL PALMITATE	8CRQ2TH63M	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 8 equally ranked IID candidates
Butylene Glycol	BUTYLENE GLYCOL	3XUS85K0RA	SYSTEM / TOPICAL		1400 mg	Exact identifier — unii candidate 2 equally ranked IID candidates
Ascorbyl Palmitate	ASCORBYL PALMITATE	QN83US2B0N	SUPPOSITORY / RECTAL		16 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
.Alpha.-Tocopherol Acetate	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	CAPSULE / ORAL	2 mg		Exact identifier — unii candidate 3 equally ranked IID candidates
Phenoxyethanol	PHENOXYETHANOL	HIE492ZZ3T	GEL / TOPICAL		14 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
Hyaluronate Sodium	HYALURONATE SODIUM	YSE9PPT4TH	INJECTION, SUSPENSION / INTRAMUSCULAR		23 mg	Exact identifier — unii candidate 5 equally ranked IID candidates
Phenoxyethanol	PHENOXYETHANOL	HIE492ZZ3T	CREAM, AUGMENTED / TOPICAL		10 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
Ascorbyl Palmitate	ASCORBYL PALMITATE	QN83US2B0N	SYSTEM / TOPICAL	0.04 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
Cyclomethicone 5	CYCLOMETHICONE 5	0THT5PCI0R	AEROSOL, FOAM / TOPICAL		144 mg	Exact identifier — unii candidate 3 equally ranked IID candidates
Ethylene Oxide	ETHYLENE OXIDE	JJH7GNN18P	SHAMPOO / TOPICAL	2.7 %w/w		Exact identifier — unii candidate
Hyaluronate Sodium	HYALURONATE SODIUM	YSE9PPT4TH	GEL / TOPICAL		463 mg	Exact identifier — unii candidate 5 equally ranked IID candidates
Isopropyl Palmitate	ISOPROPYL PALMITATE	8CRQ2TH63M	CREAM / TOPICAL		112 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
Isopropyl Palmitate	ISOPROPYL PALMITATE	8CRQ2TH63M	LOTION / TOPICAL	5 %w/w		Exact identifier — unii candidate 8 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
a9bbadd5-6e2d-4221-b508-a9719779b3ce			d83f0f88-8112-47dc-9bc5-c56f86dec51a	2012-01-20	Warnings	Exact identifier spl id: a9bbadd5-6e2d-4221-b508-a9719779b3ce spl set id: d83f0f88-8112-47dc-9bc5-c56f86dec51a

Reported adverse events (FAERS/openFDA)#

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