KARYNG COMPLETE SPF SUNSCREEN LIGHT/MEDIUM- sunscreen cream

KARYNG Complete SPF Sunscreen by

Drug Labeling and Warnings

KARYNG Complete SPF Sunscreen by is a Otc medication manufactured, distributed, or labeled by Karyng LLC, KDC/ONE SOCAL LABORATORIES, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Titanium Dioxide 5.75%

Zinc Oxide 14.5%

PURPOSE

Sunscreen

WARNINGS

For external use only.

WHEN USING

Do not get into eyes. Rinse with water to remove.

STOP USE

Stop use and ask a doctor if rash or irritation occurs.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions:

Apply liberally 15 minutes before sun exposure.

Reapply after 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-2pm

Wear long-sleeved shirts, pants, hats and sunglasses

Children under six months of age, ask a doctor

USER SAFETY WARNINGS

Sun Alert. Limiting sun exposure, wearing protective clothing, and using suncreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

OTHER SAFETY INFORMATION

Protect the product in this container from excessive heat and direct sun

INACTIVE INGREDIENT

Water (Aqua), 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

Helps prevent sunburn. If used as directed with other sun protection measures (See Sun Alert), decreases the risk of skin cancer and early skinaging by the sun.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KARYNG COMPLETE SPF SUNSCREEN  LIGHT/MEDIUM
sunscreen cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85321-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	14.5 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5.75 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIPOTASSIUM GLYCYRRHIZATE (UNII: CA2Y0FE3FX)
ECHINACEA PURPUREA (UNII: QI7G114Y98)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
GLYCERIN (UNII: PDC6A3C0OX)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
STEARETH-2 (UNII: V56DFE46J5)
STEARETH-21 (UNII: 53J3F32P58)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CITRUS GRANDIS (GRAPEFRUIT) PEEL OIL (UNII: 8U3877WD44)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
XANTHAN GUM (UNII: TTV12P4NEE)
STEARIC ACID (UNII: 4ELV7Z65AP)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
PROPANEDIOL (UNII: 5965N8W85T)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
ALUMINA (UNII: LMI26O6933)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85321-001-02	1 in 1 BOX	04/01/2025
1		50 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/01/2025

Labeler - Karyng LLC (016040944)

Establishment
Name	Address	ID/FEI	Business Operations
KDC/ONE SOCAL LABORATORIES, LLC		118384240	manufacture(85321-001)