FDA.reportPublic FDA data

Shopko Beauty Moisturizing Dandruff

Manufacturer
Apollo Health and Beauty Care Inc.
Effective date
2018-02-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:54:36

Label at a glance#

ProductShopko Beauty Moisturizing Dandruff
Active ingredientSELENIUM SULFIDE
Label structure8 sections

Indications and uses

for the relief of flaking and itching associated with dandruff and seborrheic dermatitis and to help prevent the chance of recurrence.

Dosage and administration

shake well, wet hair, massage onto scalp and rinse. for best results, use at least twice a week or as directed by a doctor.

Storage and handling

store at room temperature.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Selenium Sulfide 1%

Purpose

OTC - PURPOSE SECTION

Anti-dandruff, Anti-seborrheic dermatitis

Uses

INDICATIONS & USAGE SECTION

for the relief of flaking and itching associated with dandruff and seborrheic dermatitis and to help prevent the chance of recurrence.

Warnings

WARNINGS SECTION

For external use only.

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

you have seborrheic dermatitis in areas other than the scalp.

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes. If contact occurs, rinse thoroughly with water.
  • for use on color-treated or permed hair, rinse thoroughly.
Stop use and ask a doctor if

OTC - STOP USE SECTION

condition worsens or does not improve after regular use of this product as directed.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well, wet hair, massage onto scalp and rinse.
  • for best results, use at least twice a week or as directed by a doctor.

Other information

STORAGE AND HANDLING SECTION

store at room temperature.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Sodium Laureth Suflate, Distearyl Phthalic Acid Amide, Sodium Chloride, Cocamidopropyl Betaine, Titanium Dioxide, Sodium Stearoyl Lactylate, Fragrance (Parfum), Dimethicone, Citric Acid, Sodium Citrate, Aloe Barbadensis Leaf Juice, Hydroxypropyl Methylcellulose, Methylchloroisothiazolinone, Methylisothiazolinone. Blue 1 (CI 42090).

Questions or comments?

OTC - QUESTIONS SECTION

1-866-695-3030

Label copy

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of the labelImage of the label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
204642selenium sulfide 1 % Medicated ShampooPSN1
204642selenium sulfide 10 MG/ML Medicated ShampooSCD1
204642selenium sulfide 1 % Lotion ShampooSY1
204642selenium sulfide 1 % Medicated ShampooSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130010994000191GTIN-13: 0010994000191
EAN-13: 0010994000191
GTIN-12: 010994000191
UPC-A: 010994000191
GTIN storage (14 digits): 00010994000191		22594L.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63148-004-112024-01-30C16284748780-11030e365-219c-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63148-004-11Shopko Beauty Moisturizing Dandruff325 mL in 1 BOTTLE, PLASTICSHAMPOO3251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63148-004SHOPKO BEAUTY MOISTURIZING DANDRUFF (SELENIUM SULFIDE) SHAMPOO [APOLLO HEALTH AND BEAUTY CARE INC.]1Legacy NDC, 1 package rows20180216_42f2f8ee-21d5-4746-93be-d06c4260ffb1.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63148-00463148-004-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
SELENIUM SULFIDEZ69D9E381QACTIB
WATER059QF0KO0RIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
DISTEARYL PHTHALAMIC ACID5552GSZ9LIIACT
SODIUM CHLORIDE451W47IQ8XIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SODIUM STEAROYL LACTYLATEIN99IT31LNIACT
DIMETHICONE92RU3N3Y1OIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM CITRATE1Q73Q2JULRIACT
ALOE VERA LEAFZY81Z83H0XIACT
HYPROMELLOSES3NXW29V3WOIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
FD&C BLUE NO. 1H3R47K3TBDIACT

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
b4d6f10a-1fff-4334-9c2f-8b1e0848009742f2f8ee-21d5-4746-93be-d06c4260ffb12018-02-16WarningsExact identifier
spl id: b4d6f10a-1fff-4334-9c2f-8b1e08480097
spl set id: 42f2f8ee-21d5-4746-93be-d06c4260ffb1

Reported adverse events (FAERS/openFDA)#

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