FDA.reportPublic FDA data

Theraderm Platinum Protection Facial Sunscreen SPF 40

Manufacturer
Therapon Inc
Effective date
2024-11-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:37:55

Label at a glance#

ProductTheraderm Platinum Protection Facial Sunscreen SPF 40
Active ingredientOCTOCRYLENE, OCTISALATE, ZINC OXIDE
Label structure7 sections

Indications and uses

Helps prevent sunburn. Higher SPF gives more sunburn protection. 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 and as needed. Children under 6 months of age: ask a doctor. Reapply: after 80 minutes of swimming or sweating, immediately after towel drying, and at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly us...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octocrylene 10.00%

Octisalate 5.00%

Zinc oxide 4.00%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn. Higher SPF gives more sunburn protection. 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

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. • Rinse with water to remove.• Do not puncture or incinerate. Contents underpressure. • Do not store it at temperatures above 120°F.

Stop use and ask a doctor

OTC - STOP USE SECTION

  • if rash or irritation develops and lasts.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

• If swallowed, get medical help or contact a Poison Control Center right away.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure and as needed. Children under 6 months of age: ask a doctor. Reapply: after 80 minutes of swimming or sweating, immediately after towel drying, and at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF 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

INACTIVE INGREDIENT SECTION

Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Ascorbyl Palmitate (Vitamin C), Butyloctyl Salicylate, Camellia Sinensis (Green Tea) Extract, Caprylic/ Capric Triglyceride, Cetearyl Alcohol, Cetearyl Glucoside, Cetyl Alcohol, Citric Acid, Cocos Nucifera (Coconut) Oil, Ethylhexylglycerin, Glyceryl Stearate SE, Isododecane, C13-14 Isoparaffin, Laureth-7, dl-Panthenol, Phenoxyethanol, Polyacrylamide, Polysorbate-20, Sodium Hyaluronate, Squalane, Stearyl Alcohol, Tocopheryl Acetate (Vitamin E), Trimethylsiloxysilicate, Zemea (Corn) Propanediol.

Package Labeling: 20ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer PackageOuter PackageInner PackageInner Package

Package Labeling: 118ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Package2Outer Package2Inner Package2Inner Package2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66428-567-00Theraderm Platinum Protection Facial Sunscreen SPF 401 in 1 BOXLOTION11
66428-567-00Theraderm Platinum Protection Facial Sunscreen SPF 4020 mL in 1 TUBELOTION201
66428-567-04Theraderm Platinum Protection Facial Sunscreen SPF 401 in 1 BOXLOTION11
66428-567-04Theraderm Platinum Protection Facial Sunscreen SPF 40118 mL in 1 TUBELOTION1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66428-567THERADERM PLATINUM PROTECTION FACIAL SUNSCREEN SPF 40 (OCTOCRYLENE, OCTISALATE, ZINC OXIDE) LOTION [THERAPON INC]1Current NDC, 4 package rows20241121_1fea6ad8-4d33-4f7c-800c-1bee644bd97f.zip

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66428-56766428-567-00, 66428-567-04

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
NameUNIIKind
ALLANTOIN344S277G0ZIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ASCORBYL PALMITATEQN83US2B0NIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
CETYL ALCOHOL936JST6JCNIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
COCONUT OILQ9L0O73W7LIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
ISODODECANEA8289P68Y2IACT
C13-14 ISOPARAFFINE4F12ROE70IACT
LAURETH-7Z95S6G8201IACT
PANTHENOLWV9CM0O67ZIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
SODIUM HYALURONATEYSE9PPT4THIACT
SQUALANEGW89575KF9IACT
STEARYL ALCOHOL2KR89I4H1YIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CORN0N8672707OIACT
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB
ZINC OXIDESOI2LOH54ZACTIM

Source Document#

Source XML

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Theraderm Platinum Protection Facial Sunscreen SPF 40OCTOCRYLENE, OCTISALATE, ZINC OXIDETherapon Inc1fea6ad8-4d33-4f7c-800c-1bee644bd97f2024-11-19WarningsExact identifier
ndc (package): 66428-567-04
ndc (package): 66428-567-00
ndc (product): 66428-567
ndc11 (package): 66428056700
ndc11 (package): 66428056704
spl id: 2740d21d-abbe-c2cc-e063-6294a90ace2c
spl set id: 1fea6ad8-4d33-4f7c-800c-1bee644bd97f

Reported adverse events (FAERS/openFDA)#

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