FDA.reportPublic FDA data

TOPCARE EVERYDAY CONTINUOUS BROAD SPECTRUM SPF 50

Product NDC
36800-239
11-digit product format
368000239
Labeler code
36800
Product ID
36800-239_2487dce5-9228-ab05-e063-6294a90a41ed
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form
SPRAY
Route
TOPICAL
Labeler
TOPCO ASSOCIATES LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-01-04
Substance
AVOBENZONE; OCTISALATE; HOMOSALATE; OCTOCRYLENE
Active strength
30; 50; 100; 50 mg/g; mg/g; mg/g; mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
TOPCARE EVERYDAY CONTINUOUS BROAD SPECTRUM SPF 50
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/g
OCTISALATE50 mg/g
HOMOSALATE100 mg/g
OCTOCRYLENE50 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
4X49Y0596WInternal UNII lookup
V06SV4M95SInternal UNII lookup
5A68WGF6WMInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c8c12a5a-59f5-6515-e053-2995a90a58f7Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-239-37TOPCARE EVERYDAY CONTINUOUS BROAD SPECTRUM SPF 50156 g in 1 CANSPRAY1562
36800-239-62TOPCARE EVERYDAY CONTINUOUS BROAD SPECTRUM SPF 503 in 1 PACKAGESPRAY32
36800-239-63TOPCARE EVERYDAY CONTINUOUS BROAD SPECTRUM SPF 502 in 1 PACKAGESPRAY22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-239TOPCARE EVERYDAY CONTINUOUS BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) SPRAY [TOPCO ASSOCIATES LLC]2Current NDC, Legacy NDC, 3 package rows20241017_c8c12a5a-59f5-6515-e053-2995a90a58f7.zip

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 321 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gin Amber Beauty Mineral Sunscreen Broad Spectrum SPF 25 BB CreamZINC OXIDEGin Amber Beauty LLC32f48fe4-5788-449e-9ed8-9cd8b2ecc1c02023-11-14WarningsExact identifier
application number: M020
Private Label SPF 50 80 min Water ResistantHOMOSALATE, OCTISALATE, ZINC OXIDE SUNSCREENSwiss-American CDMO, LLC8849fa88-24c8-410d-b16e-60da38288f982023-11-14WarningsExact identifier
application number: M020
Cetaphil Sheer Mineral Face Liquid Sunscreen SPF 50ZINC OXIDEGalderma Laboratories, L.P.0d09b812-b3ca-4214-bed7-7e21ee3288b72023-11-14WarningsExact identifier
application number: M020
DAYWEAR ADVANCED MULTI-PROTECTION ANTI-OXIDANT 24H-MOISTURE CREME BROAD SPECTRUM SPF15AVOBENZONE, HOMOSALATE, OCTISALATEESTEE LAUDER INC0a0bfe4a-53b6-5b7c-e063-6394a90a23ec2023-11-13WarningsExact identifier
application number: M020
Bull Frog SPF 50 Mosquito Coast Sunscreen Plus Inspect RepellentAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBULLFROG BRANDS, LLC.f70b39c6-9f40-f5c1-e053-6394a90a1d432023-11-13WarningsExact identifier
application number: M020
Bull Frog SPF 50AVOBENZONE 3.00% HOMOSALATE 15.00% OCTISALATE 5.00% OCTOCRYLENE 10.00%Bullfrog Brands, LLCc90fc29e-d9fe-a6c9-e053-2995a90a69b32023-11-13WarningsExact identifier
application number: M020
Tropical Sands, SPF-50 Broad Spectrum SunscreenTITANIUM DIOXIDE, ZINC OXIDEElements Brands, Inc.493551d0-10a0-3d78-e054-00144ff8d46c2023-11-11WarningsExact identifier
application number: M020
Tropical Sands SPF-30 Broad Spectrum SunscreenTITANIUM DIOXIDE, ZINC OXIDEElements Brands, Inc.494a7886-d677-1648-e054-00144ff8d46c2023-11-11WarningsExact identifier
application number: M020
Tropical Sands SPF-30 Broad Spectrum SunscreenTITANIUM DIOXIDE, ZINC OXIDEElements Brands, Inc.ab691543-e37a-487a-912e-56d2e0e4d30a2023-11-11WarningsExact identifier
application number: M020
LBri Pure nNatural Oil Free MoisturizerOCTINOXATE, AVOBENZONE, OCTISALATEL'Bri Health & Beauty47f6ab9e-fa47-496a-e054-00144ff8d46c2023-11-11WarningsExact identifier
application number: M020
PURE HAVEN BODY SPF 30TITANIUM DIOXIDE, ZINC OXIDEPure haven, LLC6f298fcd-8a97-8f66-e053-2991aa0adb102023-11-11WarningsExact identifier
application number: M020
Sunstation All-Natural SPF 30 SunscreenTITANIUM DIOXIDE, ZINC OXIDESunstation USA, LLC499d366a-a7f1-6070-e054-00144ff88e882023-11-11WarningsExact identifier
application number: M020
PURE HAVEN Face Sunscreen SPF-30ZINC OXIDEPure Haven, LLC1fff88a0-4d23-4cd7-872e-1a0b8c6803422023-11-11WarningsExact identifier
application number: M020
Pure Haven EssentialsTITANIUM DIOXIDE, ZINC OXIDEPure Haven LLC4bccc017-266d-11ce-e054-00144ff8d46c2023-11-11WarningsExact identifier
application number: M020
No BS SPF20 MoisturizerOCTINOXATE, AVOBENZONE, OCTOCRYLENEProduct Management LLC690f68fa-d110-4a75-9a14-04aac1be45842023-11-11WarningsExact identifier
application number: M020
koa protect our ocean life OXYBENZONE FREE Broad Spectrum SPF 30 UVA UVB Protection SunscreenTITANIUM DIOXIDE, ZINC OXIDEKapa'ihi, Inc66e5eb1b-4ef0-459d-8428-b3e2f221bc852023-11-11WarningsExact identifier
application number: M020
Sea Star Sparkle SPF-50 PARTY CAKEOCTINOXATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDEMJ Products Association, LLC8cfaf1b6-0f25-4770-9760-2440b2c153b72023-11-11WarningsExact identifier
application number: M020
Sea Star Sparkle SPF-50 VERY BERRYOCTINOXATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDEMJ Products Association, LLC88c403ea-7c78-423e-b05e-1e17c21c5a532023-11-11WarningsExact identifier
application number: M020
FITGLOW Vita Shield Hyaluronic Primer SPF-30ZINC OXIDEFITGLOW BEAUTY LLCb9ba7783-74ca-4736-8a60-1692158590472023-11-11WarningsExact identifier
application number: M020
BLUE MONARCH Tinted SPF-50 (Rose Gold)ZINC OXIDEBlue Monarch, LLC9ba00a03-1015-4946-8c9b-5ef377a32e4b2023-11-11WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-239-3736800023937156 g in 1 CAN (36800-239-37) 156 g2017-01-040000-00-00NoNoCurrent
36800-239-62368000239623 CAN in 1 PACKAGE (36800-239-62) / 156 g in 1 CAN (36800-239-37) 3 can2017-01-040000-00-00NoNoCurrent
36800-239-63368000239632 CAN in 1 PACKAGE (36800-239-63) / 156 g in 1 CAN (36800-239-37) 2 can2017-01-040000-00-00NoNoCurrent