FDA.reportPublic FDA data

Skin Medicinals SM Clear Broad Spectrum SPF 50

Manufacturer
SKIN MEDICINALS LLC
Effective date
2026-10-01
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
daily-update
Hydrated at
2026-10-10 01:02:30

Label at a glance#

ProductSkin Medicinals SM Clear Broad Spectrum SPF 50
Active ingredientZINC OXIDE, OCTINOXATE
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 reapply after 80 minutes of swimming or sweating immediatelyafter towel drying at least every 2 hours Sun protectlon 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 broad spectrum SPF of 15 or higher and other sun protection measures including limit time in the sun, especi...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide - 9.0%

Octinoxate - 7.5%

Purpose

OTC - PURPOSE SECTION

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

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 

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberally 15 minutes before sun exposure
  • reapply after 80 minutes of swimming or sweating
  • immediatelyafter towel drying
  • at least every 2 hours
  • Sun protectlon MeasuresSpending time In the sun increases your risk of skin cancer and early skin aging. To decrease this 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 am-2pm
  • wear Long-sleeve shirts, parts, hats, and sunglasses
  • children under month Ask a doctor

Other Information

SPL UNCLASSIFIED SECTION

"Protect the product In this container from excessive heat or direct sun.

Questions or Comments

OTC - QUESTIONS SECTION

call 312-535-9924

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Cyclopentasiloxane, Niacinamide, Neopentyl Glycol Diheptanoate, Butylene Glycol, Potassium Cetyl Phosphate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Silica, Phenoxyethanol, Triethoxycaprylylsilane, Polyisobutene, Lactic Acid Sodium Hyaluronate, PEG-7 Trimethylolpropane Coconut Ether, Ethylhexylglycerin, Sorbitan Isostearate, BHT.

Package Labelling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Label.jpgOuter Label.jpgInner Label.jpgInner Label.jpg

85748-001-01 Sample Carton and Primary Container

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

85748-001-01 Packaging and Labeling

Sample Carton FOPSample Carton FOP

Sample Carton DFPSample Carton DFP

Sample tube

Sample primary tubeSample primary tube

Sample tube drug facts panel

Sample primary DFPSample primary DFP

85748-001-03 and 85748-001-04 Packaging and Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

85748-001-03 Box

Full Size Box FOPFull Size Box FOP

Full size box drug facts panel

Full size Box Drug Facts PanelFull size Box Drug Facts Panel

Full size label

Full size primaryFull size primary

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130850063884044GTIN-13: 0850063884044
EAN-13: 0850063884044
GTIN-12: 850063884044
UPC-A: 850063884044
GTIN storage (14 digits): 00850063884044		Outer Label.jpg
QR code linkQR Codebit.ly/4nJ8TMe?r=qr85748 001 01 Sample Carton DFP.jpg

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

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85748-00185748-001-00, 85748-001-02, 85748-001-01, 85748-001-04, 85748-001-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIM
OCTINOXATE4Y5P7MUD51ACTIB
CYCLOMETHICONE 50THT5PCI0RIACT
WATER059QF0KO0RIACT
NIACINAMIDE25X51I8RD4IACT
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
PHENOXYETHANOLHIE492ZZ3TIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
LACTIC ACID, UNSPECIFIED FORM33X04XA5ATIACT
HYALURONATE SODIUMYSE9PPT4THIACT
PEG-7 TRIMETHYLOLPROPANE COCONUT ETHERMVJ3AD73GGIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22026-07-08weekly-update2026-07-17 21:44:09
12025-05-01full-release2026-06-01 01:01:50

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
Skin Medicinals SM Clear Broad Spectrum SPF 50ZINC OXIDE, OCTINOXATESKIN MEDICINALS LLC364e9bac-85c4-afbd-e063-6394a90aba822026-07-08WarningsExact identifier
ndc (package): 85748-001-00
ndc (product): 85748-001
ndc11 (package): 85748000100
spl set id: 364e9bac-85c4-afbd-e063-6394a90aba82

Reported adverse events (FAERS/openFDA)#

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