KOPARI ANTIOXIDANT FACE SHIELD MINERAL SPF 30- zinc oxide lotion

KOPARI Antioxidant Face Shield Mineral SPF 30 by

Drug Labeling and Warnings

KOPARI Antioxidant Face Shield Mineral SPF 30 by is a Otc medication manufactured, distributed, or labeled by COSMAX USA, CORPORATION, COSMAX USA. CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Zinc Oxide 14.4%

PURPOSE

Purpose

Sunscreen

USES

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging cause by the sun

Warnings

Warnings

For extenal use only

Do not useon damaged or broken skin

When using this productkeep out of eyes. Rinse with water to remove.

Stop use and ask a doctor ifrash occurs

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

DIRECTIONS

Directions

• Shake well. Apply 3 pumps and smooth on to the face and neck as the last step of your skicare routine in the morning.

• Apply generously and evenly 15 minutes before sun exposure
  • Reapply at least every 2 hours.
  • Use 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 10 a.m. - 2p.m.

-wear long-sleeved shirts, pants, hats and sunglasses

Children under 6 months of age: Ask a doctor

INACTIVE INGREDIENT

Inactive ingredients: water/aqua/eau,propanediol,c12-15 alkyl benzoate,glycerin,lsoamyl laurate,butyloctyl salicylate,styrene/acrylates copolymer,pentylene glycol,cetearyl alcohol,polysorbate 60,potassium cetyl phosphate,sodium hyaluronate,rubus ldaeus (raspberry) seed oil,glycine soja (soybean) oil,oryza sativa (rice) extract, oryza sativa (rice) germ extract, panax ginseng root extract,argania spinosa kernel oil,bisabololzea mays (corn) oil,1,2-hexanediol,butylene glycol,caprylyl glycol,sodium acrylate/sodium acryloyldimethyl taurate copolymer,lsohexadecanepolyhydroxystearic acid,sodium citrate,triethoxycaprylylsilane,polyglyceryl-3 diisostearate,sorbitan oleate,citric acid,tocopheryl acetate,ethyl hexanediol,polysorbate 80,cholecalciferol

OTHER INFORMATION

Other information

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

QUESTIONS or COMMENTS

Questions or comments?

Call (858) 252 0099

PRINCIPAL DISPLAY PANEL

Primary Packaging

PRINCIPAL DISPLAY PANEL

Secondary Package

INGREDIENTS AND APPEARANCE

KOPARI ANTIOXIDANT FACE SHIELD MINERAL SPF 30 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68577-154
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	14.4 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
CORN OIL (UNII: 8470G57WFM)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ARGAN OIL (UNII: 4V59G5UW9X)
WATER (UNII: 059QF0KO0R)
PROPANEDIOL (UNII: 5965N8W85T)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GLYCERIN (UNII: PDC6A3C0OX)
ISOAMYL LAURATE (UNII: M1SLX00M3M)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYSORBATE 60 (UNII: CAL22UVI4M)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
RUBUS IDAEUS SEED (UNII: M3CL7US2ZG)
SOYBEAN OIL (UNII: 241ATL177A)
ASIAN GINSENG (UNII: CUQ3A77YXI)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ISOHEXADECANE (UNII: 918X1OUF1E)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
LEVOMENOL (UNII: 24WE03BX2T)
RICE GERM (UNII: 7N2B70SFEZ)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
ETHOHEXADIOL (UNII: M9JGK7U88V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68577-154-01	1 in 1 CARTON	06/01/2023
1		45 mg 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	06/01/2023

Labeler - COSMAX USA, CORPORATION (010990210)

Registrant - COSMAX USA, CORPORATION (010990210)

Establishment
Name	Address	ID/FEI	Business Operations
COSMAX USA. CORPORATION		010990210	manufacture(68577-154)