Skin Medicinals SM Clear Broad Spectrum SPF 50

Product NDC
85748-001
11-digit product format
857480001
Labeler code
85748
Product ID
85748-001_364e9bbe-0bc9-b047-e063-6394a90a61b9
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE, OCTINOXATE
Dosage form
CREAM
Route
TOPICAL
Labeler
SKIN MEDICINALS LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-05-01
Substance
OCTINOXATE; ZINC OXIDE
Active strength
75; 90 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
Skin Medicinals SM Clear Broad Spectrum SPF 50
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE75 mg/mL
ZINC OXIDE90 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4Y5P7MUD51, 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
85748-001-00Skin Medicinals SM Clear Broad Spectrum SPF 5058 mL in 1 BOTTLE, PUMPCREAM581

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85748-001-008574800010058 mL in 1 BOTTLE, PUMP (85748-001-00) 58 ml2025-05-01NoNoHistorical