FDA.reportPublic FDA data

KOPARI Sun Shield Soft Glow Daily Face SPF30

Manufacturer
COSMAX USA, CORPORATION | COSMAX USA. CORPORATION
Effective date
2024-12-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:48:55

Label at a glance#

ProductKOPARI Sun Shield Soft Glow Daily Face SPF30
Active ingredientAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE
Label structure9 sections

Indications and 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

Dosage and administration

Directions Apply generously and evenly 15 minutes before sun exposure Reapply At least every 40 minutes 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 ...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Homosalate 10%

Octisalate 5%

Octocrylene 4%

Avobenzone 3%

OTC - PURPOSE SECTION

Purpose

Sunscreen

USES

INDICATIONS & USAGE SECTION

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 SECTION

Warnings

For extenal use only

OTC - DO NOT USE SECTION

Do not useon damaged or broken skin

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor ifrash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Directions

  • Apply generously and evenly 15 minutes before sun exposure
    • Reapply At least every 40 minutes
    • 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 SECTION

Inactive ingredients:Isododecane, Dimethicone/Bis-lsobutyl PPG-20 Crosspolymer, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Caprylyl Methicone, Caprylic/Capric Triglyceride, Dimethicone/Vinyl Dimethicone Crosspolymer, Mica, Titanium Dioxide (Cl 77891), Tocopheryl Acetate, Silica, Tin Oxide, Tocopherol.

OTHER INFORMATION

OTHER SAFETY INFORMATION

Other information

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

QUESTIONS or COMMENTS

OTHER SAFETY INFORMATION

Questions or comments?

Call (858) 252 0099

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Packaging

DisplayDisplay

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68577-153-01KOPARI Sun Shield Soft Glow Daily Face SPF30100 mg in 1 BOTTLE, SPRAYSPRAY1002
68577-153-01KOPARI Sun Shield Soft Glow Daily Face SPF301 in 1 CARTONSPRAY12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68577-153KOPARI SUN SHIELD SOFT GLOW DAILY FACE SPF30 (OCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATE) SPRAY [COSMAX USA, CORPORATION]2Current NDC, 2 package rows20241228_0d3673da-822b-09e2-e063-6394a90a348e.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68577-15368577-153-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISODODECANEA8289P68Y2IACT
DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMERO4I3UFO6ZFIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
MICAV8A1AW0880IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STANNOUS OXIDEJB2MV9I3LSIACT
TOCOPHEROLR0ZB2556P8IACT
PHENOXYETHANOLHIE492ZZ3TIACT

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
KOPARI Sun Shield Soft Glow Daily Face SPF30OCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATECOSMAX USA, CORPORATION0d3673da-822b-09e2-e063-6394a90a348e2024-12-26WarningsExact identifier
ndc (package): 68577-153-01
ndc (product): 68577-153
ndc11 (package): 68577015301
spl id: 2a269ead-815c-9047-e063-6294a90ad224
spl set id: 0d3673da-822b-09e2-e063-6394a90a348e

Reported adverse events (FAERS/openFDA)#

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