FDA.reportPublic FDA data

Medline

Manufacturer
Medline Industries, LP
Effective date
2025-11-04
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:42:07

Label at a glance#

ProductMedline
Active ingredientZINC OXIDE
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 children under 6 months of age: ask a doctor reapply: after 80 mins. of swimming or sweating immediately after towel drying at least every 2 hours Sun Protection 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 a Broad Spectrum SPF value of 15 or higher and other sun prote...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc oxide 20% w/w

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
  • children under 6 months of age: ask a doctor
  • reapply:
  • after 80 mins. of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours

Sun Protection 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 a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

  • limit time in sun, especially from 10 a.m. to 2 p.m.
  • wear long sleeve shirts, pants, hats and sunglasses

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf extract, behenyl behenate, butyrospermum parkii (shea) butter, caprylic/capric triglyceride, cocos nucifera (coconut) oil, euphorbia cerifera (candelilla) wax, helianthus annuus (sunflower) seed oil, helianthus annuus (sunflower) seed wax, polyhydroxystearic acid, ricinus communis (castor) seed oil, simmondsia chinensis (jojoba) seed oil, squalane, theobroma cacao (cocoa) seed butter, tocopherol

Other information

OTHER SAFETY INFORMATION

protect this product from excessive heat and direct sun

Questions?

OTC - QUESTIONS SECTION

1.800.290.0577

Manufacturing Information

SPL UNCLASSIFIED SECTION

www.medline.com

©2022 Medline and Medline Remedy are registered trademarks of Medline Industries, LP.

Manufactured for: Medline industries, LP, Three Lakes Drive, Northfield, IL 60093 USA

Made in USA of Foreign and Domestic Materials

1-800-MEDLINE

REF: MSCSUNSTIK05O

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label pdpLabel pdplabel drug factslabel drug facts

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130193489104908GTIN-13: 0193489104908
EAN-13: 0193489104908
GTIN-12: 193489104908
UPC-A: 193489104908
GTIN storage (14 digits): 00193489104908		53329-220_MSCSUNSTIK05O_drug facts.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53329-220-072025-11-04C16284748780-11e7a6dab-1a95-a2ce-e063-dadaa90aadf7220 RemedySunscreen Stick
53329-220-072025-11-04C16284748780-11e7a6dab-1a95-a2ce-e063-dadaa90aadf7220 RemedySunscreen Stick
53329-220-072024-07-30C16284748780-11e7a6dab-1a95-a2ce-e063-dadaa90aadf7220 RemedySunscreen Stick
53329-220-072024-07-30C16284748780-11e7a6dab-1a95-a2ce-e063-dadaa90aadf7220 RemedySunscreen Stick

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-220-07Medline14 g in 1 CONTAINERSTICK144

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53329-22053329-220-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
BEHENYL BEHENATEK8NU647RJ0IACT
CANDELILLA WAXWL0328HX19IACT
HELIANTHUS ANNUUS SEED WAX42DG15CHXVIACT
SQUALANEGW89575KF9IACT
ZINC OXIDESOI2LOH54ZACTIB
SHEA BUTTERK49155WL9YIACT
JOJOBA OIL724GKU717MIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
CASTOR OILD5340Y2I9GIACT
COCOA BUTTER512OYT1CRRIACT
ALOE VERA LEAFZY81Z83H0XIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
COCONUT OILQ9L0O73W7LIACT
SUNFLOWER OIL3W1JG795YIIACT
TOCOPHEROLR0ZB2556P8IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32022-12-14full-release2026-05-31 23:52:30

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
MedlineZINC OXIDEMedline Industries, LPcadba3bc-4a06-872a-e053-2995a90ab4472025-11-04WarningsExact identifier
ndc (package): 53329-220-07
ndc (product): 53329-220
ndc11 (package): 53329022007
spl id: 42cb7fbf-bd03-52a4-e063-6394a90a2490
spl set id: cadba3bc-4a06-872a-e053-2995a90ab447

Reported adverse events (FAERS/openFDA)#

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