FDA.reportPublic FDA data

Soft Touch

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#

ProductSoft Touch
Active ingredientZINC OXIDE
Label structure13 sections

Label contents#

Full prescribing information#

DESCRIPTION SECTION

DMK Soft Touch Sunscreen Broad Spectrum SPF 30 water resistant 80 minutes non-greasy formula 60ml (2 fl oz)DMK Soft Touch Sunscreen Broad Spectrum SPF 30 water resistant 80 minutes non-greasy formula 60ml (2 fl oz)

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Zinc Oxide (23.1%)Active Ingredients: Zinc Oxide (23.1%)

OTC - PURPOSE SECTION

Purpose: SunscreenPurpose: Sunscreen

INDICATIONS & USAGE SECTION

Uses:Uses:

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

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 Soft Touch SunscreenDMK Soft Touch Sunscreen

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81537-105-032026-01-29C16284748780-149896155-aafd-586f-e063-e6dba90add90Soft Touch SPF 30
81537-105-042026-01-29C16284748780-149896155-aafd-586f-e063-e6dba90add90Soft Touch SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81537-105-03Soft Touch120 mL in 1 BOTTLE, PUMPLOTION1202
81537-105-04Soft Touch60 mL in 1 BOTTLE, PLASTICLOTION602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81537-105SOFT TOUCH (SUNSCREEN WITH SPF 30) LOTION [DANNE MONTAGUE KING]22 package rows20240720_0774809c-3168-fd07-e063-6394a90aeeac.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
81537-10581537-105-04, 81537-105-03

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

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-37fd-74bf-e063-6294a90af5db0774809c-3168-fd07-e063-6394a90aeeac2024-07-19WarningsExact identifier
spl id: 1d9c8a9c-37fd-74bf-e063-6294a90af5db
spl set id: 0774809c-3168-fd07-e063-6394a90aeeac

Reported adverse events (FAERS/openFDA)#

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