FDA.reportPublic FDA data

Antioxidant Face Shield Mineral SPF30

Manufacturer
Koco Life LLC | Cosmax Usa, Corporation
Effective date
2024-06-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:14:34

Label at a glance#

ProductAntioxidant Face Shield Mineral SPF30
Active ingredientZINC OXIDE
Label structure9 sections

Indications and 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

Dosage and administration

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...

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 14.14%

Purpose

OTC - PURPOSE SECTION

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

Uses

INDICATIONS & USAGE SECTION

• 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

WARNINGS SECTION

• For external use only

OTC - DO NOT USE SECTION

• Do not use on damaged or broken skin

OTC - WHEN USING SECTION

• When using this product keep out of eyes

• Rinse with water to remove

OTC - STOP USE SECTION

• Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

• Keep out of reach of children

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

STORAGE AND HANDLING SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call (858) 252-0099

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Kopari

Antioxidant

Face Shield

Mineral SPF 30

Broad Spectrum

UVA-UVB

1.5 FL. OZ. | 45 mL

11

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84130-007-11Antioxidant Face Shield Mineral SPF3045 mL in 1 BOTTLE, PUMPCREAM451
84130-007-12Antioxidant Face Shield Mineral SPF301 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84130-007ANTIOXIDANT FACE SHIELD MINERAL SPF30 (ZINC OXIDE) CREAM [KOCO LIFE LLC]1Current NDC, 2 package rows20240702_1c31a971-0402-e12a-e063-6294a90ac91d.zip

Products#

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

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84130-00784130-007-11, 84130-007-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW)5Z4DPO246AIACT
SODIUM CITRATE1Q73Q2JULRIACT
RICE GERM7N2B70SFEZIACT
ASIAN GINSENGCUQ3A77YXIIACT
ETHOHEXADIOLM9JGK7U88VIACT
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)1DXE3F3OZXIACT
SOYBEAN OIL241ATL177AIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
ISOAMYL LAURATEM1SLX00M3MIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
CORN OIL8470G57WFMIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
PROPANEDIOL5965N8W85TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
POLYSORBATE 806OZP39ZG8HIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYGLYCERYL-3 DIISOSTEARATE46P231IQV8IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
GLYCERINPDC6A3C0OXIACT
PENTYLENE GLYCOL50C1307PZGIACT
POLYSORBATE 60CAL22UVI4MIACT
ARGAN OIL4V59G5UW9XIACT
ISOHEXADECANE918X1OUF1EIACT
LEVOMENOL24WE03BX2TIACT
CHOLECALCIFEROL1C6V77QF41IACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
SORBITAN MONOOLEATE06XEA2VD56IACT
HYALURONATE SODIUMYSE9PPT4THIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
WATER059QF0KO0RIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
RASPBERRY SEED OIL9S8867952AIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT

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
Antioxidant Face Shield Mineral SPF30ZINC OXIDEKoco Life LLC1c31a971-0402-e12a-e063-6294a90ac91d2024-06-28WarningsExact identifier
ndc (package): 84130-007-12
ndc (package): 84130-007-11
ndc (product): 84130-007
ndc11 (package): 84130000711
ndc11 (package): 84130000712
spl id: 1c31a971-0403-e12a-e063-6294a90ac91d
spl set id: 1c31a971-0402-e12a-e063-6294a90ac91d

Reported adverse events (FAERS/openFDA)#

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