FDA.reportPublic FDA data

THRIVE- Buildable Blur CC Cream SPF 40- 240 Medium Tan (warm-neutral undertones)

Manufacturer
COSMAX USA, CORPORATION | COSMAX USA. CORPORATION
Effective date
2024-12-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:48:51

Label at a glance#

ProductBuildable Blur
Active ingredientHOMOSALATE, ZINC OXIDE, OCTISALATE
Label structure10 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 caused by sun

Dosage and administration

Directions For sunscreen use: 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 the risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and oth...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Homosalate 9.0%

Octisalate 4.5%

Zinc Oxide 7.8%

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 caused by sun

WARNINGS SECTION

Warnings

For external 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 doctorif rash 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

For sunscreen use:

  • 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 the risk, regularly use a sunscreen with 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-sleeve shirts, pants, hats, and sunglasses.

OTHER INFORMATION

OTHER SAFETY INFORMATION

Other information

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

INACTIVE INGREDIENT SECTION

Inactive ingredients

AQUA/WATER/EAU, DIMETHICONE, BUTYLOCTYL SALICYLATE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, GLYCERIN, PENTYLENE GLYCOL, SODIUM CHLORIDE, TRIBEHENIN, BUTYLENE GLYCOL, CETYL PEG/PPG-10/1 DIMETHICONE, METHYL METHACRYLATE CROSSPOLYMER, PHENYL TRIMETHICONE, TETRAHEXYLDECYL ASCORBATE, LINUM USITATISSIMUM (LINSEED) SEED EXTRACT, DICAPRYLYL CARBONATE, TRIETHOXYCAPRYLYLSILANE, CAPRYLYL METHICONE, DIMETHICONE CROSSPOLYMER, ETHYLHEXYL PALMITATE, ALUMINUM HYDROXIDE, MICA, QUATERNIUM-90 BENTONITE, SODIUM PHYTATE, PROPYLENE CARBONATE, HYDROXYACETOPHENONE, CAPRYLYL GLYCOL, [+/- TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491, 77492, 77499), ULTRAMARINES (CI 77007)].

Primary Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Primary Package Tube_ArtworkTube_Artwork

Secondary Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer package

Outer PkgOuter Pkg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
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3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
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810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68577-135-01Buildable Blur30 mg in 1 TUBECREAM302
68577-135-01Buildable Blur1 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68577-135BUILDABLE BLUR (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM [COSMAX USA, CORPORATION]2Current NDC, 2 package rows20241228_06c5efde-42e1-e4fc-e063-6394a90a491d.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
68577-13568577-135-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
ETHYLHEXYL PALMITATE2865993309IACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
FLAX SEED4110YT348CIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
MICAV8A1AW0880IACT
QUATERNIUM-90 BENTONITE97K5YEF88CIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
DIMETHICONE92RU3N3Y1OIACT
TRIBEHENIN8OC9U7TQZ0IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5)V2W71V8T0XIACT
PHYTATE SODIUM88496G1ERLIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
PENTYLENE GLYCOL50C1307PZGIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)UF7620L1W6IACT
PROPYLENE CARBONATE8D08K3S51EIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FERRIC OXIDE RED1K09F3G675IACT
ULTRAMARINE BLUEI39WR998BIIACT
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE25G622K2RAIACT
GLYCERINPDC6A3C0OXIACT
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMEREG97988M5QIACT
CAPRYLYL GLYCOL00YIU5438UIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
HOMOSALATEV06SV4M95SACTIB
ZINC OXIDESOI2LOH54ZACTIB
OCTISALATE4X49Y0596WACTIB

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
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06c5efde-42e1-e4fc-e063-6394a90a491d2024-12-25WarningsExact identifier
ndc (package): 68577-135-01
ndc (product): 68577-135
ndc11 (package): 68577013501
spl id: 2a2554dd-40d1-5ee2-e063-6394a90a872c
spl set id: 06c5efde-42e1-e4fc-e063-6394a90a491d

Reported adverse events (FAERS/openFDA)#

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