FDA.reportPublic FDA data

DMK MD Satinscreen

Manufacturer
Danne Montague King | Creative Essences, Inc.
Effective date
2024-07-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:15:38

Label at a glance#

ProductDMK MD Satinscreen
Active ingredientZINC OXIDE
Label structure12 sections

Label contents#

Full prescribing information#

DESCRIPTION SECTION

DMK MD SatinScreen Broad Spectrum SPF 40 Sunscreen water resistant (80 minutes) 120 ml (4 fl oz)DMK MD SatinScreen Broad Spectrum SPF 40 Sunscreen water resistant (80 minutes) 120 ml (4 fl oz)

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Zinc Oxide (24.99%)Active Ingredients: Zinc Oxide (24.99%)

OTC - PURPOSE SECTION

Purpose: SunscreenPurpose: Sunscreen

WARNINGS SECTION

Warnings:Warnings:

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

see attached inactive ingredients imagesee attached inactive ingredients image

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 - KEEP OUT OF REACH OF CHILDREN SECTION

Warnings: ..... Keep out of reach of children....Warnings: ..... 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.

INDICATIONS & USAGE 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 MD SatinScreen Broad Spectrum SPF 40 Sunscreen water resistant (80 minutes) 120 ml (4 fl oz)DMK MD SatinScreen Broad Spectrum SPF 40 Sunscreen water resistant (80 minutes) 120 ml (4 fl oz)

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81537-106-032026-01-29C16284748780-149896155-ab00-586f-e063-e6dba90add90DMK MD Satinscreen SPF 40
81537-106-052026-01-29C16284748780-149896155-ab00-586f-e063-e6dba90add90DMK MD Satinscreen SPF 40

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81537-106-03DMK MD Satinscreen120 mL in 1 TUBELOTION1202
81537-106-05DMK MD Satinscreen2 mL in 1 POUCHLOTION22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81537-106DMK MD SATINSCREEN (BROAD SPECTRUM SPF 40 SUNSCREEN) LOTION [DANNE MONTAGUE KING]22 package rows20240720_07792518-524e-569f-e063-6294a90aaa22.zip

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81537-10681537-106-03, 81537-106-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
GREEN TEA LEAFW2ZU1RY8B0IACT
CYCLOMETHICONE 6XHK3U310BAIACT
POLYGLYCERYL-3 RICINOLEATEMZQ63P0N0WIACT
COCONUT OILQ9L0O73W7LIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S)5F4963KLHSIACT
YEAST, UNSPECIFIED3NY3SM6B8UIACT
GARLICV1V998DC17IACT
POLYSORBATE 806OZP39ZG8HIACT
ISOHEXADECANE918X1OUF1EIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
WATER059QF0KO0RIACT
ISOSTEARIC ACIDX33R8U0062IACT
GLYCERINPDC6A3C0OXIACT
ACETYL HEXAPEPTIDE-149ZWR266MZIACT
POLYGONUM AVICULARE WHOLEM990N03611IACT
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER9NH1UDD2RRIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
PHYSALIS ANGULATAW4TKW9D5GGIACT
ZINC OXIDESOI2LOH54ZACTIB
DICAPRYLYL CARBONATE609A3V1SUAIACT
TOCOPHEROLR0ZB2556P8IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
LECITHIN, SOYBEAN1DI56QDM62IACT

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
1d9c8ac6-569d-0b1c-e063-6394a90ad37007792518-524e-569f-e063-6294a90aaa222024-07-19WarningsExact identifier
spl id: 1d9c8ac6-569d-0b1c-e063-6394a90ad370
spl set id: 07792518-524e-569f-e063-6294a90aaa22

Reported adverse events (FAERS/openFDA)#

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