FDA.reportPublic FDA data

Head and Shoulders ® Royal Oils Daily Moisture Scalp Cream

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2025-12-18
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:26:51

Label at a glance#

ProductHead and Shoulders Royal Oils Daily Moisture Scalp
Active ingredientPYRITHIONE ZINC
Label structure10 sections

Indications and uses

helps prevent recurrence of flaking and itching associated with dandruff.

Dosage and administration

• Apply to affected areas one to four times daily or as directed by a doctor. • Twist the cap open. Place tip directly onto scalp (damp or dry) • Gently squeeze the bottle while moving tip fromfront to back of your scalp. Repeat to cover your entire scalp. • Massage for even distribution. Do not rinse.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Pyrithione zinc 0.1%

Purpose

OTC - PURPOSE SECTION

Anti-dandruff

Uses

INDICATIONS & USAGE SECTION

helps prevent recurrence of flaking and itching associated with dandruff.

Warnings

WARNINGS SECTION

SPL UNCLASSIFIED SECTION

For external use only.

OTC - WHEN USING SECTION

When using this product

  • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• Apply to affected areas one to four times daily or as directed by a doctor.

• Twist the cap open. Place tip directly onto scalp (damp or dry)

• Gently squeeze the bottle while moving tip fromfront to back of your scalp. Repeat to cover your entire scalp.

• Massage for even distribution. Do not rinse.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, cocos nucifera (coconut) oil, cetyl alcohol, stearamidopropyl dimethylamine, fragrance, stearyl alcohol, quaternium-18, hydroxyethylcellulose, phenoxyethanol, benzyl alcohol, dimethicone, PEG-2M, cetearyl alcohol, methylparaben, propylparaben, oleyl alcohol, glyceryl stearate, citric acid, polysorbate 60.

Questions (or comments)?

OTC - QUESTIONS SECTION

1-800-723-9569

SPL UNCLASSIFIED SECTION

Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 150 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

head &
shoulders ®
pyrithione zinc dandruff treatment

ROYAL OILS

DAILY MOISTURE

SCALP CREAM

WITH COCONUT OIL

MOISTURIZES SCALP TO

PREVENT DRYNESS AND ITCH*

SULFATE, DYE &

MINERAL OIL FREE

5.0 FL OZ
(150 mL)

HSHS

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2104630Head & Shoulders 0.1 % Topical CreamPSN7
247812zinc pyrithione 0.1 % Topical CreamPSN7
2104630zinc pyrithione 1 MG/ML Topical Cream [Head & Shoulders]SBD7
247812zinc pyrithione 1 MG/ML Topical CreamSCD7
2104630Head & Shoulders 0.1 % Topical CreamSY7
2104630Head & Shoulders 1 MG/ML Topical CreamSY7
247812zinc pyrithione 0.1 % Topical CreamSY7

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130037000779483GTIN-13: 0037000779483
EAN-13: 0037000779483
GTIN-12: 037000779483
UPC-A: 037000779483
GTIN storage (14 digits): 00037000779483		HS.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-307-15Head and Shoulders Royal Oils Daily Moisture Scalp150 mL in 1 BOTTLE, PLASTICCREAM1507

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69423-30769423-307-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYSORBATE 60CAL22UVI4MIACT
DIMETHICONE92RU3N3Y1OIACT
OLEYL ALCOHOL172F2WN8DVIACT
POLYETHYLENE OXIDE 100000V46Y6OJ5QBIACT
WATER059QF0KO0RIACT
STEARYL ALCOHOL2KR89I4H1YIACT
CETYL ALCOHOL936JST6JCNIACT
PHENOXYETHANOLHIE492ZZ3TIACT
BENZYL ALCOHOLLKG8494WBHIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
STEARAMIDOPROPYL DIMETHYLAMINEK7VEI00UFRIACT
QUATERNIUM-18O7757NO1VLIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
COCONUT OILQ9L0O73W7LIACT
GLYCOL STEARATE0324G66D0EIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT

Source Document#

Source XML · Source PDF

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
Head and Shoulders Royal Oils Daily Moisture ScalpPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company7b1f81e1-1fee-5be2-e053-2a91aa0aa0632025-12-18WarningsExact identifier
ndc (package): 69423-307-15
ndc (product): 69423-307
ndc11 (package): 69423030715
spl id: 463fc0f5-351a-bf1c-e063-6394a90a0d4d
spl set id: 7b1f81e1-1fee-5be2-e053-2a91aa0aa063

Reported adverse events (FAERS/openFDA)#

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