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 327 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RADIANCE Silky Mineral Primer Sunscreen SPF-42 HONEYTITANIUM DIOXIDE, ZINC OXIDESANTO REMEDIO LLC867a88df-9a18-447f-8301-2ec91566302e2023-11-06WarningsExact identifier
application number: M020
CALIFORNIA MANGO SPF-30 SUNSCREENAVOBENZONE, OCTISALATE, OCTOCRYLENECALMANGO, INCe0de0504-763d-4518-8a9c-67724077701d2023-11-06WarningsExact identifier
application number: M020
KOVR All-Natural SPF-30 Moisturizing Sunscreen for MenTITANIUM DIOXIDE, ZINC OXIDEACTIVE LIFE INCbf766aab-a52d-41e8-a06a-f2e536d2219b2023-11-06WarningsExact identifier
application number: M020
PROJECT REEF SPF-50ZINC OXIDE, TITANIUM DIOXIDEProject Reef LLC6bcd470c-6994-4d28-8370-4cc9d68e1e782023-11-06WarningsExact identifier
application number: M020
BB OSKIN Broad Spectrum SPF-30TITANIUM DIOXIDE, OCTOCRYLENE, ZINC OXIDEO'Skin Studio NYd84cca38-b673-484e-aa25-df58d904d4d32023-11-06WarningsExact identifier
application number: M020
MIAMI MD SUN SHIELD Broad Spectrum SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBRAND BOLT LLC3a53d53a-129a-41c3-a8e7-c1b1bb98d8bd2023-11-06WarningsExact identifier
application number: M020
JOY SPRING Kids Mineral Sunscreen SPF-30ZINC OXIDEJOYSPRING HOLDINGS LLC76613a3d-f4a8-4961-b36a-d84b4e10dea02023-11-06WarningsExact identifier
application number: M020
Aruba Aloe Sport Line Lip Balm Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEAruba Aloe Balm NV80461b6d-b1b7-4220-894d-8bd4259094742023-11-06WarningsExact identifier
application number: M020
Sport Broad Spectrum SPF50 Water Resistant 80 minutes Mineral Sunscreen UVA UVB Protection StickZINC OXIDEAruba Aloe Balm NV3201cc8b-5fee-4f3b-a826-e349786d1b322023-11-06WarningsExact identifier
application number: M020
Broad Spectrum SPF50 Water Resistant (80 minutes) Mineral Sunscreen UVA UVB Protection Stick for KidsZINC OXIDEAruba Aloe Balm NV25f060eb-628c-4a11-b1d7-06922ee86b242023-11-06WarningsExact identifier
application number: M020
SPF30 SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCITSALATEZhejiang Ayan Biotech Co., Ltd.44321dff-1a61-452f-8324-6de2a196db512023-11-06WarningsExact identifier
application number: M020
SPF30 SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCITSALATEZhejiang Ayan Biotech Co., Ltd.cac6f5e5-91c2-4978-bffd-5ca2a75906372023-11-06WarningsExact identifier
application number: M020
SPF15 SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEZhejiang Ayan Biotech Co.,Ltd.68035415-47c3-4eed-93f4-bb6b26c9149a2023-11-06WarningsExact identifier
application number: M020
SPF30 Sunscreen and Antibacterial Hand SanitizerALCOHOL, AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEZhejiang Ayan Biotech Co., Ltd.b5e2458f-8e84-4e57-b6f7-e428a94c97a42023-11-06WarningsExact identifier
application number: M020
SPF30 Sunscreen and SPF15AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEZhejiang Ayan Biotech Co.,Ltd.6c40259b-565a-46d0-90d0-ccc1867645522023-11-06WarningsExact identifier
application number: M020
Image Skincare Prevention Plus Daily Ultimate ProtectionHOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE SUNSCREENSwiss-American CDMO, LLC3473f94c-5faf-4415-9605-f58ec93cd2682023-11-06WarningsExact identifier
application number: M020
Image MD Restoring Lip Enhancer SPF15SUNSCREENSwiss-American CDMO, LLCe296579e-ba30-4a29-afe0-bb51f863369c2023-11-06WarningsExact identifier
application number: M020
Image Prevention Refiner Primer SPF50ZINC OXIDE, TITANIUM DIOXIDE SUNSCREENSwiss-American CDMO, LLC0e490f11-666c-420c-8c12-b45cd238ce472023-11-06WarningsExact identifier
application number: M020
Image Prevention Plus Professional Ultimate Protection Moisturizer SPF50HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE SUNSCREENSwiss-American CDMO, LLCd807f94a-f933-47d9-938f-b91f663af0782023-11-06WarningsExact identifier
application number: M020
Farmasi BB Beauty Balm Cream SPF 15- 01 LightTITANIUM DIOXIDEFarmasi US LLC97c1da03-b79c-46a3-a9f0-7aeb94ed66da2023-11-05WarningsExact 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