FDA.reportPublic FDA data

Sheer Confidence Antiperspirant Deodorant

Manufacturer
Melaleuca Inc. | KDC/ONE Development Corporation, Inc.
Effective date
2021-09-02
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:42:15

Label at a glance#

ProductSheer Confidence Antiperspirant Deodorant Caribbean Sunset
Active ingredientALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY
Label structure12 sections

Storage and handling

Other information do not freeze or store above 115°F (46°C)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Aluminum zirconium tetrachlorohydrex gly (19% Anhydrous)

Purpose

OTC - PURPOSE SECTION

Antiperspirant

INDICATIONS & USAGE SECTION

Use reduces underarm perspiration

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on broken skin

OTC - ASK DOCTOR SECTION

Ask a dcotor before use if you have kidney disease

OTC - STOP USE SECTION

Stop use if rash or irritation occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions ■ turn dial to raise product ■ apply to underarms only

STORAGE AND HANDLING SECTION

Other information do not freeze or store above 115°F (46°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

cyclopentasiloxane, stearyl alcohol, C12-15 alkyl benzoate, PPG-14 butyl ether, petrolatum, hydrogenated castor oil, phenyl trimethicone, cetyl alcohol, talc, fragrance, silica, behenyl alcohol, allantoin, aloe barbadensis leaf juice, camella sinensis (green tea) leaf extract, melaleuca alternifolia (tea tree) leaf oil

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Front and back labelFront and back label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54473-278-022025-01-30C16284748780-19d75b9d0-aa74-f424-e053-dadaa90a57ceSheer Confidence Antiperspirant Deodorant Caribbean Sunset
54473-278-022020-03-19C16284748780-19d75b9d0-aa74-f424-e053-dadaa90a57ceSheer Confidence Antiperspirant Deodorant Caribbean Sunset
54473-278-022020-01-31C16284748780-19d75b9d0-aa74-f424-e053-dadaa90a57ceSheer Confidence Antiperspirant Deodorant Caribbean Sunset

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54473-278-02Sheer Confidence Antiperspirant DeodorantCaribbean Sunset57 g in 1 APPLICATORSTICK573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54473-278SHEER CONFIDENCE ANTIPERSPIRANT DEODORANT CARIBBEAN SUNSET (ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY (19% ANHYDROUS)) STICK [MELALEUCA INC.]3Legacy NDC, 1 package rows20210903_6890d821-bfeb-70e4-e053-2991aa0a40b7.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54473-27854473-278-02

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
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
ALLANTOIN344S277G0ZIACT
ALOE VERA LEAFZY81Z83H0XIACT
CETYL ALCOHOL936JST6JCNIACT
CYCLOMETHICONE 50THT5PCI0RIACT
DOCOSANOL9G1OE216XYIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
PETROLATUM4T6H12BN9UIACT
STEARYL ALCOHOL2KR89I4H1YIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
PPG-14 BUTYL ETHERR199TJT95TIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TALC7SEV7J4R1UIACT
TEA TREE OILVIF565UC2GIACT
ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY8O386558JEACTIB

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
cb059e51-792b-3223-e053-2a95a90a3a946890d821-bfeb-70e4-e053-2991aa0a40b72021-09-02WarningsExact identifier
spl id: cb059e51-792b-3223-e053-2a95a90a3a94
spl set id: 6890d821-bfeb-70e4-e053-2991aa0a40b7

Reported adverse events (FAERS/openFDA)#

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