Theraderm Platinum Protection Facial Sunscreen SPF 40

Product NDC
66428-567
11-digit product format
664280567
Labeler code
66428
Product ID
66428-567_2740d21d-abbe-c2cc-e063-6294a90ace2c
Type
HUMAN OTC DRUG
Nonproprietary name
OCTOCRYLENE, OCTISALATE, ZINC OXIDE
Dosage form
LOTION
Route
TOPICAL
Labeler
Therapon Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-11-01
Substance
OCTISALATE; OCTOCRYLENE; ZINC OXIDE
Active strength
50; 100; 40 mg/mL; mg/mL; mg/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Theraderm Platinum Protection Facial Sunscreen SPF 40
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTISALATE50 mg/mL
OCTOCRYLENE100 mg/mL
ZINC OXIDE40 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4X49Y0596W, 5A68WGF6WM, SOI2LOH54Z

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
66428-567-00664280567001 TUBE in 1 BOX (66428-567-00) / 20 mL in 1 TUBE1 tube2024-11-06NoNoCurrent
66428-567-04664280567041 TUBE in 1 BOX (66428-567-04) / 118 mL in 1 TUBE1 tube2024-11-01NoNoCurrent