FDA.reportPublic FDA data

Avobenzone, Homosalate, and Octisalate

Manufacturer
Thrive Causemetics | Cosway Company, Inc.
Effective date
2024-11-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:34:35

Label at a glance#

ProductFiltered Effects Protecting Primer Broad Spectrum SPF 37 Sunscreen Water Resistant (80 minutes)
Active ingredientAvobenzone, Homosalate, Octisalate
Label structure10 sections

Indications and uses

Helps prevent sunburn If used as directed with other sun protection measures (see Directions ), decreases the risk Skin cancer and early skin aging caused by the sun.

Dosage and administration

For sunscreen use: Apply liberally 15 minutes before sun exposure. reapply: after 80 minutes of swimming or sweating. immediately after towel drying. at least every 2 hours. 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 includ...

Storage and handling

Protect this product from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Avobenzone 3.0%Sunscreen
Homosalate 10.0%Sunscreen
Octisalate 5.0%Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions), decreases the risk Skin cancer and early skin aging caused by the sun.

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • 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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

For sunscreen use:

  • Apply liberally 15 minutes before sun exposure.
  • reapply: after 80 minutes of swimming or sweating.
  • immediately after towel drying.
  • at least every 2 hours.
  • 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 am. - 2 pm.
    • Wear long-sleeved shirts, pants, and sunglasses.
  • Children under 6 months of age: Ask a doctor.

Other information

STORAGE AND HANDLING SECTION

  • Protect this product from excessive heat and direct sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

ISODODECANE, DIMETHICONE CROSSPOLYMER, DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER, POLYESTER-7, NEOPENTYL GLYCOL DIHEPTANOATE, POLYESTER-8, DICAPRYLYL CARBONATE, POLYMETHYLSILSESQUIOXANE, VP/EICOSENE COPOLYMER, POLYHYDROXYSTEARIC ACID, NELUMBO NUCIFERA FLOWER EXTRACT, NYMPHAEA CAERULEA FLOWER EXTRACT, HYDROLYZED SODIUM HYALURONATE, PANTHENYL ETHYL ETHER, MUSA SAPIENTUM (BANANA) FLOWER EXTRACT, TREMELLA FUCIFORMIS (MUSHROOM) EXTRACT, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, TRIMETHYLSILOXYSILICATE, DIMETHICONE, DIETHYLHEXYL SYRINGYLIDENEMALONATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, PROPANEDIOL, GLYCERIN, TRIETHOXYCAPRYLYLSILANE, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, SPIRULINA MAXIMA EXTRACT, WATER (AQUA), ORYZA SATIVA (RICE) STARCH, CAPRYLYL GLYCOL, TITANIUM DIOXIDE (CI 77891)

SPL UNCLASSIFIED SECTION

Dist. by Thrive Causemetics, Inc.
Los Angeles, CA 90045

PRINCIPAL DISPLAY PANEL - 30 mL Tube Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

thrive™
causemetics

filtered
effects™

PROTECTING PRIMER

SPF
37

Hydro Reset Solution™

Broad Spectrum SPF 37 Sunscreen
Water Resistant (80 minutes)

1 fl oz / 30 mL

PRINCIPAL DISPLAY PANEL - 30 mL Tube Box
PRINCIPAL DISPLAY PANEL - 30 mL Tube Box

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77365-006-01Filtered Effects Protecting Primer Broad Spectrum SPF 37 Sunscreen Water Resistant (80 minutes)30 mL in 1 TUBEGEL302
77365-006-01Filtered Effects Protecting Primer Broad Spectrum SPF 37 Sunscreen Water Resistant (80 minutes)1 in 1 BOXGEL12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77365-006FILTERED EFFECTS PROTECTING PRIMER BROAD SPECTRUM SPF 37 SUNSCREEN WATER RESISTANT (80 MINUTES) (AVOBENZONE, HOMOSALATE, AND OCTISALATE) GEL [THRIVE CAUSEMETICS]22 package rows20241107_e93c0dc9-2bad-4be9-8f3b-24bb2ae44a8f.zip

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77365-00677365-006-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Name, UNII, Kind table
NameUNIIKind
AvobenzoneG63QQF2NOXACTIB
HomosalateV06SV4M95SACTIB
Octisalate4X49Y0596WACTIB
ISODODECANEA8289P68Y2IACT
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)UF7620L1W6IACT
DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMERO4I3UFO6ZFIACT
POLYESTER-70841698D2FIACT
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)T9296U138PIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
EICOSYL POVIDONEXQQ9MKE2BJIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
NELUMBO NUCIFERA FLOWER61W322NLDVIACT
NYMPHAEA CAERULEA FLOWERS9560USZ74IACT
HYALURONATE SODIUMYSE9PPT4THIACT
PANTHENYL ETHYL ETHERF4WMF8NX3BIACT
MUSA X PARADISIACA FLOWERDG5B0M0NGYIACT
TREMELLA FUCIFORMIS FRUITING BODYGG8N28393GIACT
SUNFLOWER OIL3W1JG795YIIACT
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)5041RX63GNIACT
DIMETHICONE92RU3N3Y1OIACT
DIETHYLHEXYL SYRINGYLIDENEMALONATE3V5U97P248IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
PROPANEDIOL5965N8W85TIACT
GLYCERINPDC6A3C0OXIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
SAFFLOWER OIL65UEH262ISIACT
ARTHROSPIRA MAXIMA9K7IG15M0QIACT
WATER059QF0KO0RIACT
STARCH, RICE4DGK8B7I3SIACT
CAPRYLYL GLYCOL00YIU5438UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

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
2e937ea2-365a-41d4-97da-6c8b04fbf6c3e93c0dc9-2bad-4be9-8f3b-24bb2ae44a8f2024-11-05WarningsExact identifier
spl id: 2e937ea2-365a-41d4-97da-6c8b04fbf6c3
spl set id: e93c0dc9-2bad-4be9-8f3b-24bb2ae44a8f

Reported adverse events (FAERS/openFDA)#

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