ANTIOXIDANT FACE SHIELD MINERAL SPF30- zinc oxide cream

Antioxidant Face Shield Mineral SPF30 by

Drug Labeling and Warnings

Antioxidant Face Shield Mineral SPF30 by is a Otc medication manufactured, distributed, or labeled by Koco Life LLC, Cosmax Usa, Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Zinc Oxide 14.14%

Purpose

Zinc Oxide 14.14%............Sunscreen

Uses

Helps prevent sunburn

If used as directed with othersun protection measures (see Directions), decrease therisk of skin cancer and early skin aging caused by the sun

Warnings

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 product is swallowed, get medical help or contact aPoison Control Center right away

Directions

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

Apply generously and evenly 15 minutes before sun exposure. Reappply 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 10 a.m.- 2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses. Children under 6 months: Ask doctor

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, Triethoxycaprylylsilane, 1,2-Hexanediol, Polyhydroxystearic Acid, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Argania Spinosa Kernel Oil, Caprylyl Glycol, Tocopheryl Acetate, lsohexadecane, Polysorbate 80, Rubus ldaeus (Raspberry) Seed Oil, Glycine Soja (Soybean) Oil, Bisabolol, Sorbitan Oleate, Butylene Glycol, Citric Acid, Sodium Citrate. Polyglyceryl-3 Diisostearate, Oryza Saliva (Rice) Extract, Oryza Saliva (Rice) Germ Extract, Sodium Hyaluronate, Zea Mays (Corn) Oil, Panax Ginseng Root Extract, Ethyl Hexanediol, Cholecalciferol.

Other information

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

Questions or comments?

Call (858) 252-0099

PRINCIPAL DISPLAY PANEL

Kopari

Antioxidant

Face Shield

Mineral SPF 30

Broad Spectrum

UVA-UVB

1.5 FL. OZ. | 45 mL

INGREDIENTS AND APPEARANCE

ANTIOXIDANT FACE SHIELD MINERAL SPF30 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84130-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	141.4 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
RICE GERM (UNII: 7N2B70SFEZ)
ASIAN GINSENG (UNII: CUQ3A77YXI)
ETHOHEXADIOL (UNII: M9JGK7U88V)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
SOYBEAN OIL (UNII: 241ATL177A)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ISOAMYL LAURATE (UNII: M1SLX00M3M)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CORN OIL (UNII: 8470G57WFM)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PROPANEDIOL (UNII: 5965N8W85T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
GLYCERIN (UNII: PDC6A3C0OX)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
POLYSORBATE 60 (UNII: CAL22UVI4M)
ARGAN OIL (UNII: 4V59G5UW9X)
ISOHEXADECANE (UNII: 918X1OUF1E)
LEVOMENOL (UNII: 24WE03BX2T)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
RASPBERRY SEED OIL (UNII: 9S8867952A)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84130-007-12	1 in 1 CARTON	06/28/2024
1	NDC: 84130-007-11	45 mL 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	06/28/2024

Labeler - Koco Life LLC (046650159)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax Usa, Corporation		010990210	manufacture(84130-007)