FDA.reportPublic FDA data

Acu Moist

Manufacturer
Danne Montague King
Effective date
2024-07-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:15:37

Label at a glance#

ProductAcu Moist
Active ingredientZINC OXIDE
Label structure13 sections

Label contents#

Full prescribing information#

DESCRIPTION SECTION

DMK Acu Moist Hydrating Lotion with SPF 15 relieves skin dryness 120 ml (4 fl oz)DMK Acu Moist Hydrating Lotion with SPF 15 relieves skin dryness 120 ml (4 fl oz)

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Zinc Oxide (8.67%)Active Ingredients: Zinc Oxide (8.67%)

OTC - PURPOSE SECTION

Purpose: SunscreenPurpose: Sunscreen

INDICATIONS & USAGE SECTION

Uses: Apply daily to the face and neck over your other DMK Skincare products. Apply generously and evenly to all exposed skin before sun exposure.Uses: Apply daily to the face and neck over your other DMK Skincare products. Apply generously and evenly to all exposed skin before sun exposure.

WARNINGS SECTION

Warnings: (For external use only)Warnings: (For external use only)

INSTRUCTIONS FOR USE SECTION

Directions: apply generously 15 minutes before sun exposure. reapply: after 80 minutes of swimming or sweating. immediately after towel drying. at least every 2 hours.Directions: apply generously 15 minutes before sun exposure. reapply: after 80 minutes of swimming or sweating. immediately after towel drying. at least every 2 hours.

INACTIVE INGREDIENT SECTION

Inactive ingredients:Inactive ingredients:

OTHER SAFETY INFORMATION

Other Information: Exclusive formula provides increased dermal hydration and improves the skin's overall appearance. Keep product from excessive heat and away from direct sun.Other Information: Exclusive formula provides increased dermal hydration and improves the skin's overall appearance. Keep product from excessive heat and away from direct sun.

OTC - QUESTIONS SECTION

Questions or comments? Call toll free 1-888-DANNE-4-UQuestions or comments? Call toll free 1-888-DANNE-4-U

OTC - ASK DOCTOR SECTION

Warnings: ......Stop use and ask a doctor ir rash or irritation develops....Warnings: ......Stop use and ask a doctor ir rash or irritation develops....

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Warnings: (For external use only) .... Keep out of reach of children.....Warnings: (For external use only) .... Keep out of reach of children.....

DOSAGE & ADMINISTRATION SECTION

Directions: apply generously 15 minutes before sun exposure. reapply: after 80 minutes of swimming or sweating. immediately after towel drying. at least every 2 hours.Directions: apply generously 15 minutes before sun exposure. reapply: after 80 minutes of swimming or sweating. immediately after towel drying. at least every 2 hours.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DMK Acu Moist SPF 15DMK Acu Moist SPF 15

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81537-103-012026-01-29C16284748780-149896155-aa73-586f-e063-e6dba90add90Acu Moist SPF 15
81537-103-022026-01-29C16284748780-149896155-aa73-586f-e063-e6dba90add90Acu Moist SPF 15
81537-103-032026-01-29C16284748780-149896155-aa73-586f-e063-e6dba90add90Acu Moist SPF 15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81537-103-01Acu Moist120 mL in 1 BOTTLE, PUMPLOTION1202
81537-103-02Acu Moist50 mL in 1 BOTTLE, PUMPLOTION502
81537-103-03Acu Moist15 mL in 1 BOTTLE, PUMPLOTION152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81537-103ACU MOIST (HYDRATING LOTION WITH SPF 15) LOTION [DANNE MONTAGUE KING]23 package rows20240720_06c00fab-af75-d477-e063-6294a90a1083.zip

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
81537-10381537-103-01, 81537-103-02, 81537-103-03

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
MAGNOLIA CHAMPACA FLOWER OILWER1P18I1JIACT
CYCLOMETHICONE 50THT5PCI0RIACT
POLYSORBATE 60CAL22UVI4MIACT
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)8Z5ZAL5H3VIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
DIMETHICONE92RU3N3Y1OIACT
SAFFLOWER OIL65UEH262ISIACT
TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONEX75PL53TZJIACT
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S)RLA2U05Z4QIACT
ALLANTOIN344S277G0ZIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
CHLOROXYLENOL0F32U78V2QIACT

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
1d9c87f4-c5de-e000-e063-6394a90a530406c00fab-af75-d477-e063-6294a90a10832024-07-19WarningsExact identifier
spl id: 1d9c87f4-c5de-e000-e063-6394a90a5304
spl set id: 06c00fab-af75-d477-e063-6294a90a1083

Reported adverse events (FAERS/openFDA)#

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