FDA.reportPublic FDA data

Bubble Solar Mate Daily Mineral Sunscreen SPF 40

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#

ProductBubble Solar Mate Daily Mineral Sunscreen SPF 40
Active ingredientZINC OXIDE
Label structure10 sections

Indications and uses

Uses helps prevent sunburn

Dosage and administration

Directions Apply liberally 15 minutes before sun exposure Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating Children under 6 months of age: Ask a doctor 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 protectio...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Zinc Oxide 12%

OTC - PURPOSE SECTION

Purpose

Sunscreen

USES

INDICATIONS & USAGE SECTION

Uses

  • helps prevent sunburn

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 liberally 15 minutes before sun exposure
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating
  • Children under 6 months of age: Ask a doctor

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.

OTHER INFORMATION

OTHER SAFETY INFORMATION

Other information

  • Protect the product in this container from excessive heat and direct sun
  • Avoid storing at extreme temperatures (Below 40F and above 100F)
  • In case of serious adverse effects, please call + (651) 504-2243

INACTIVE INGREDIENT SECTION

Inactive ingredientsWater (Aqua), Isoamyl Laurate, Glycerin, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Polyglyceryl-10 Stearate, Poly C10-30 Alkyl Acrylate, Polyhydroxystearic Acid, Cetearyl Olivate, Sorbitan Olivate, Rubus Idaeus (Raspberry) Seed Oil, Panax Ginseng Root Extract, Theobroma Cacao (Cocoa) Seed Extract, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Hydroxyacetophenone, Polyglyceryl-10 Laurate, Microcrystalline Cellulose, Butylene Glycol, Xanthan Gum, Cellulose Gum, Phenoxyethanol.

QUESTIONS or COMMENTS

OTHER SAFETY INFORMATION

Questions or comments?

Call+1 (651) 504-2243

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TubeTubePrimary Package(Inner)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer CartonOuter CartonOuter Package (Secondary)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68577-156-01Bubble Solar Mate Daily Mineral Sunscreen SPF 401 in 1 CARTONCREAM12
68577-156-01Bubble Solar Mate Daily Mineral Sunscreen SPF 4050 mg in 1 TUBECREAM502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68577-156BUBBLE SOLAR MATE DAILY MINERAL SUNSCREEN SPF 40 (ZINC OXIDE) CREAM [COSMAX USA, CORPORATION]2Current NDC, 2 package rows20241228_0d35fa3c-e6eb-d9ff-e063-6394a90a5a6e.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68577-15668577-156-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISOAMYL LAURATEM1SLX00M3MIACT
GLYCERINPDC6A3C0OXIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
POLYGLYCERYL-10 STEARATE90TF85HH91IACT
BEHENYL ACRYLATE POLYMERD64PM5UT4UIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
CETEARYL OLIVATE58B69Q84JOIACT
SORBITAN OLIVATEMDL271E3GRIACT
RASPBERRY SEED OIL9S8867952AIACT
ASIAN GINSENGCUQ3A77YXIIACT
COCOAD9108TZ9KGIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)86FQE96TZ4IACT
WATER059QF0KO0RIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
POLYGLYCERYL-10 LAURATEMPJ2Q8WI8GIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
XANTHAN GUMTTV12P4NEEIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
PHENOXYETHANOLHIE492ZZ3TIACT
ZINC OXIDESOI2LOH54ZACTIB

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
Bubble Solar Mate Daily Mineral Sunscreen SPF 40ZINC OXIDECOSMAX USA, CORPORATION0d35fa3c-e6eb-d9ff-e063-6394a90a5a6e2024-12-26WarningsExact identifier
ndc (package): 68577-156-01
ndc (product): 68577-156
ndc11 (package): 68577015601
spl id: 2a268e52-e34d-8dff-e063-6294a90a98e5
spl set id: 0d35fa3c-e6eb-d9ff-e063-6394a90a5a6e

Reported adverse events (FAERS/openFDA)#

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