FDA.reportPublic FDA data

Nutrascreen Color Balanced

Manufacturer
DMK - 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#

ProductNutrascreen Color Balanced
Active ingredientZINC OXIDE
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Zinc Oxide (20.2%)...Active Ingredients: Zinc Oxide (20.2%)...

OTC - PURPOSE SECTION

Purpose: SunscreenPurpose: Sunscreen

INDICATIONS & USAGE SECTION

Uses:Uses:

WARNINGS SECTION

Warnings:Warnings:

DESCRIPTION SECTION

DMK Nutrascreen Color Balanced Nourishing Day Cream with SPF 30DMK Nutrascreen Color Balanced Nourishing Day Cream with SPF 30

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.

INACTIVE INGREDIENT SECTION

Inactive ingredients:Inactive ingredients:

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.....

OTC - QUESTIONS SECTION

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

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DMK Nutrascreen Color Balanced Nourishing Day Cream with SPF 30 50ml (1.7 fl oz)DMK Nutrascreen Color Balanced Nourishing Day Cream with SPF 30 50ml (1.7 fl oz)

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81537-104-02Nutrascreen Color Balanced50 mL in 1 BOTTLE, PUMPLOTION502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81537-104NUTRASCREEN COLOR BALANCED (ZINC OXIDE) LOTION [DMK - DANNE MONTAGUE KING]21 package rows20240720_076171d0-7307-d126-e063-6394a90afafd.zip

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81537-10481537-104-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
CYCLOMETHICONE 50THT5PCI0RIACT
SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S)5F4963KLHSIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FILIPENDULA ULMARIA FLOWER06L18L32G6IACT
POLYGONUM AVICULARE WHOLEM990N03611IACT
POLYGLYCERYL-4 OLEATE15B05TY4GXIACT
CYCLOMETHICONE 6XHK3U310BAIACT
ALTEROMONAS MACLEODII POLYSACCHARIDESAP6XG2GR8ZIACT
FERRIC OXIDE RED1K09F3G675IACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
POTASSIUM SORBATE1VPU26JZZ4IACT
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S)RLA2U05Z4QIACT
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER9NH1UDD2RRIACT
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SODIUM BENZOATEOJ245FE5EUIACT
ZINC OXIDESOI2LOH54ZACTIB
DICAPRYLYL CARBONATE609A3V1SUAIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONEX75PL53TZJIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PENTYLENE GLYCOL50C1307PZGIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
ISOHEXADECANE918X1OUF1EIACT
POLYSORBATE 806OZP39ZG8HIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GALACTOARABINANSL4SX1O487IACT
GLYCERINPDC6A3C0OXIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

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
1d9c8a9c-37fa-74bf-e063-6294a90af5db076171d0-7307-d126-e063-6394a90afafd2024-07-19WarningsExact identifier
spl id: 1d9c8a9c-37fa-74bf-e063-6294a90af5db
spl set id: 076171d0-7307-d126-e063-6394a90afafd

Reported adverse events (FAERS/openFDA)#

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