KARYNG COMPLETE SPF SUNSCREEN MEDIUM/DARK- 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 Ingredients

Titanium Dioxide 5.75%

Zinc Oxide 14.5%

Uses

Sunscreen

Warnings

For external use only

When using this product

Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

Rash occurs

Directions

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

Ask a doctor

Keep out of reach of children

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

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

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KARYNG COMPLETE SPF SUNSCREEN  MEDIUM/DARK
sunscreen cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85321-002
Route of Administration	TOPICAL

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85321-002-02	1 in 1 BOX	04/21/2025
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(85321-002)