FDA.reportPublic FDA data

Mild Care Suncream

Manufacturer
HUMEX,INC. | Kolmar Korea
Effective date
2023-01-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:53:04

Label at a glance#

ProductMild Care Suncream
Active ingredientZINC OXIDE
Label structure7 sections

Indications and uses

Helps prevent sunburn

Dosage and administration

▪ Appy liberally 15 minutes before sun exposure ▪ Reapply at least every 2 hours ▪ Use a water-resistant sunscreen if swimming or sweating ▪ Children under 6 months of age: ask a doctor

Label contents#

Full prescribing information#

Drug Facts Active ingredient Purpose

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide(15.445) Sunscreen

Uses

OTC - PURPOSE SECTION

Helps prevent sunburn

Warnings

WARNINGS AND PRECAUTIONS SECTION

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

For external use only

Do not use on damaged or broken skin
When using this product keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if rash occurs.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

INSTRUCTIONS FOR USE SECTION

▪ Appy liberally 15 minutes before sun exposure
▪ Reapply at least every 2 hours
▪ Use a water-resistant sunscreen if swimming or sweating
▪ Children under 6 months of age: ask a doctor

Other Information

OTHER SAFETY INFORMATION

▪ protect the product in this container from excessive heat and direct sun

Inactive Ingredients

INACTIVE INGREDIENT SECTION

WATER,PROPYLHEPTYL CAPRYLATE,LAURYL POLYGLYCERYL-3POLYDIMETHYLSILOXYETHYL DIMETHICONE,ISODODECANE,ISOTRIDECYL ISONONANOATE,POLYGLYCERYL-3POLYDIMETHYLSILOXYETHYL DIMETHICONE,DISTEARDIMONIUM HECTORITE,MAGNESIUM SULFATE,TRIETHOXYCAPRYLYLSILANE,GLYCOL DIMETHACRYLATE,1,2-HEXANEDIOL,POLYHYDROXYSTEARIC ACID,GLYCERYL CAPRYLATE,CAPRYLYL GLYCOL,POLYMETHYLSILSESQUIOXANE,PANTHENOL,ETHYLHEXYLGLYCERIN,TOCOPHEROL,CERAMIDE NP,SUCROSE STEARATE,CHOLESTEROL,STEARIC ACID,CHOLESTERYL MACADAMIATE,PALMITIC ACID,SACCHARIDE ISOMERATE

Package display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

display paneldisplay panel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76344-8006-22024-07-30C16284748780-11030e365-0ff2-111a-e063-dadaa90a10e2b8f9344c-312d-b0c6-e053-2995a90acba1
76344-8006-22024-01-30C16284748780-11030e365-0ff2-111a-e063-dadaa90a10e2b8f9344c-312d-b0c6-e053-2995a90acba1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76344-8006-2Mild Care Suncream50 mL in 1 TUBECREAM502
76344-8006-2Mild Care Suncream1 in 1 BOXCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76344-8006MILD CARE SUNCREAM (ZINC OXIDE) CREAM [HUMEX,INC.]2Legacy NDC, 2 package rows20230111_b8f9344c-312d-b0c6-e053-2995a90acba1.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76344-800676344-8006-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISOTRIDECYL ISONONANOATEWEF51750MTIACT
MAGNESIUM SULFATE, UNSPECIFIEDDE08037SABIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
POLYMETHYLSILSESQUIOXANE (11 MICRONS)Z570VEV8XKIACT
PANTHENOLWV9CM0O67ZIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
TOCOPHEROLR0ZB2556P8IACT
CHOLESTERYL MACADAMIATEDFP79OD7KPIACT
PALMITIC ACID2V16EO95H1IACT
SACCHARIDE ISOMERATEW8K377W98IIACT
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S)RLA2U05Z4QIACT
CAPRYLYL GLYCOL00YIU5438UIACT
SUCROSE STEARATE274KW0O50MIACT
CHOLESTEROL97C5T2UQ7JIACT
STEARIC ACID4ELV7Z65APIACT
ZINC OXIDESOI2LOH54ZACTIB
PROPYLHEPTYL CAPRYLATE991Z19V2ODIACT
ISODODECANEA8289P68Y2IACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
GLYCOL DIMETHACRYLATE7BK5G69305IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
CERAMIDE NP4370DF050BIACT

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
f1ecb705-b0ce-b58d-e053-2a95a90a6d0fb8f9344c-312d-b0c6-e053-2995a90acba12023-01-10WarningsExact identifier
spl id: f1ecb705-b0ce-b58d-e053-2a95a90a6d0f
spl set id: b8f9344c-312d-b0c6-e053-2995a90acba1

Reported adverse events (FAERS/openFDA)#

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