FDA.reportPublic FDA data

KARYNG Complete SPF Sunscreen

Manufacturer
Karyng LLC | KDC/ONE SOCAL LABORATORIES, LLC
Effective date
2025-04-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:59:30

Label at a glance#

ProductKARYNG Complete SPF Sunscreen Medium/Dark
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure11 sections

Indications and uses

Sunscreen

Dosage and administration

Apply liberally 15 minutes before sun exposure Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating Sun protection measures spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially f...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 5.75%

Zinc Oxide 14.5%

Uses

OTC - PURPOSE SECTION

Sunscreen

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

Rash occurs

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure

Reapply at least every 2 hours

Use a water resistant sunscreen if swimming or sweating

Sun protection measures spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

Limit time in the sun, especially from 10am - 2 pm

Wear long sleeved shirts, pants, hats and sunglasses

Childern under 6 months

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact Poison Control Center right away. Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Caprylic/Capric Triglyceride, Dicaprylyl Carbonate, Glycerin, Steareth-2, Pentylene Glycol, Silica, Steareth-21, Polyhydroxystearic Acid, Cetearyl Alcohol, Echinacea Purpurea Extract, Swertia Chirata Leaf Extract, Citrus Grandis (Grapefruit) Peel Oil, Litsea Cubeba Oil,Copper Lysinate/Prolinate, Dipotassium Glycyrrhizate, Sodium Stearoyl Glutamate, Stearic Acid, Propanediol, Cetearyl Glucoside, Methylglucoside Phosphate, Lecithin, Triethoxycaprylylsilane, Isopropyl Palmitate, Sodium C14-16 Olefin Sulfonate, Trisodium Ethylenediamine Disuccinate, Alumina, Xanthan Gum, Caprylhydroxamic Acid, Caprylyl Glycol, Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499).

INDICATIONS & USAGE SECTION

Helps prevent sunburn

If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by sun.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CSMD01CSMD01

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85321-002-02KARYNG Complete SPF SunscreenMedium/Dark1 in 1 BOXCREAM11
85321-002-02KARYNG Complete SPF SunscreenMedium/Dark50 g in 1 BOTTLE, PUMPCREAM501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85321-002KARYNG COMPLETE SPF SUNSCREEN MEDIUM/DARK (SUNSCREEN) CREAM [KARYNG LLC]1Current NDC, 2 package rows20250424_335eee1e-ef1c-41da-e063-6294a90ac273.zip

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85321-00285321-002-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
PENTYLENE GLYCOL50C1307PZGIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
WATER059QF0KO0RIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
GLYCERINPDC6A3C0OXIACT
STEARETH-2153J3F32P58IACT
STEARIC ACID4ELV7Z65APIACT
PROPANEDIOL5965N8W85TIACT
CITRUS GRANDIS (GRAPEFRUIT) PEEL OIL8U3877WD44IACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
STEARETH-2V56DFE46J5IACT
CETEARYL ALCOHOL2DMT128M1SIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
ECHINACEA PURPUREAQI7G114Y98IACT
XANTHAN GUMTTV12P4NEEIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
SILICAETJ7Z6XBU4IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
ZINC OXIDESOI2LOH54ZACTIB
DIPOTASSIUM GLYCYRRHIZATECA2Y0FE3FXIACT
SODIUM C14-16 OLEFIN SULFONATEO9W3D3YF5UIACT
CAPRYLYL GLYCOL00YIU5438UIACT
TRISODIUM ETHYLENEDIAMINE DISUCCINATEYA22H34H9QIACT
ALUMINALMI26O6933IACT

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
KARYNG Complete SPF Sunscreen Medium/DarkSUNSCREENKaryng LLC335eee1e-ef1c-41da-e063-6294a90ac2732025-04-22WarningsExact identifier
ndc (package): 85321-002-02
ndc (product): 85321-002
ndc11 (package): 85321000202
spl id: 335eee1e-ef1d-41da-e063-6294a90ac273
spl set id: 335eee1e-ef1c-41da-e063-6294a90ac273

Reported adverse events (FAERS/openFDA)#

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