FDA.reportPublic FDA data

Sunscreen Emulsion SPF50plus

Product NDC
84509-002
11-digit product format
845090002
Labeler code
84509
Product ID
84509-002_2b3ecbec-979d-d07c-e063-6294a90a717a
Type
HUMAN OTC DRUG
Nonproprietary name
Octocrylene,Ethylhexyl Methoxycirnnamate,Titanium Dioxide,Ethylhexyl Salicylate
Dosage form
LOTION
Route
TOPICAL
Labeler
Guangzhou Senmai Biotechnology Co.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-16
Substance
OCTISALATE; OCTOCRYLENE; OCTINOXATE; TITANIUM DIOXIDE
Active strength
1500; 3000; 3000; 2400 mg/30mL; mg/30mL; mg/30mL; mg/30mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
Sunscreen Emulsion SPF50plus
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTISALATE1500 mg/30mL
OCTOCRYLENE3000 mg/30mL
OCTINOXATE3000 mg/30mL
TITANIUM DIOXIDE2400 mg/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
15FIX9V2JPInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1d560670-026b-bd34-e063-6394a90a9af4Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84509-002-01Sunscreen Emulsion SPF50plus30 mL in 1 BOTTLELOTION303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84509-002SUNSCREEN EMULSION SPF50PLUS (OCTOCRYLENE,ETHYLHEXYL METHOXYCIRNNAMATE,TITANIUM DIOXIDE,ETHYLHEXYL SALICYLATE) LOTION [GUANGZHOU SENMAI BIOTECHNOLOGY CO.]3Current NDC, 1 package rows20250110_1d560670-026b-bd34-e063-6394a90a9af4.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 23 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ultra Violette Preen Screen Broad Spectrum SPF 50AVONBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEGrace and Fire USA Inc.26a0fc0d-a903-2ac1-e063-6394a90a13db2026-06-01WarningsExact identifier
application number: M020
Timesavvy Hybrid XL Cushion Sun Serum SPF 50HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDEProBetter USA, Inc.82a22071-f1bd-4fab-b929-8a00ef18f0d92026-05-31WarningsExact identifier
application number: M020
Marine Screen Mineral Sunscreen Broad Spectrum SPF 50ZINC OXIDEOSEA International, LLC9aa20377-0ab9-4205-b9aa-24640a4641e72026-05-29WarningsExact identifier
application number: M020
Ciele Blush and Protect SugarZINC OXIDECiele LLC52f3a9f6-a226-6723-e063-6394a90a87062026-05-29WarningsExact identifier
application number: M020
KIEHLS DERMATOLOGIST SOLUTIONS BETTER SCREEN MINER ALL UV SERUM BROAD SPECTRUM SPF 50 PLUS MINERAL SUNSCREENTITANIUM DIOXIDE AND ZINC OXIDELOreal USA Products Inc294e6049-12b5-4b45-ae00-8ee1d9d2a1a42026-05-29WarningsExact identifier
application number: M020
Daily Mineral Sunscreen 20% Zinc OxideZINC OXIDEINTEGRATIVE AESTHETICS BOSTON, LLC52f818f4-8485-b228-e063-6294a90a9fe32026-05-29WarningsExact identifier
application number: M020
Dr.G BRIGHT TONING UP TINTED SUNSCREENZINC OXIDE, OCTISALATE, HOMOSALATEGOWOONSESANG COSMETICS CO., LTD.30d34459-b7fb-b0c6-e063-6294a90a08ac2026-05-28WarningsExact identifier
application number: M020
Dr.G GREEN MILD UP DEFENSE MINERAL SUNSCREENZINC OXIDEGOWOONSESANG COSMETICS CO., LTD.30d49f24-3e13-385f-e063-6294a90ab5c82026-05-28WarningsExact identifier
application number: M020
Dr.G R.E.D BLEMISH SOOTHING UP MOISTURE SUNSCREENHOMOSALATE, OCTISALATE, AVOBENZONEGOWOONSESANG COSMETICS CO., LTD.30d53b8a-7e35-0b2b-e063-6294a90aa8df2026-05-28WarningsExact identifier
application number: M020
Ciele Blush and Protect BerriZINC OXIDECiele LLC52e16cbc-b452-db18-e063-6394a90a40812026-05-28WarningsExact identifier
application number: M020
Ciele Blush and Protect JuneZINC OXIDECiele LLC52e1c504-f0ee-2853-e063-6394a90a31392026-05-28WarningsExact identifier
application number: M020
Ciele Blush and Protect JanuaryZINC OXIDECiele LLC52e186df-06aa-6528-e063-6294a90a38882026-05-28WarningsExact identifier
application number: M020
Ciele Blush and Protect BerriZINC OXIDECiele LLC52e1398d-b170-ea89-e063-6294a90a7d242026-05-28WarningsExact identifier
application number: M020
TIZO ULTRA NON TINTED MINERAL SUNSCREENZINC OXIDE 20%Fallien Cosmeceuticals, LTD30d30610-2e6c-418c-bbcf-4ecd7f61be932026-05-28WarningsExact identifier
application number: M020
Creme FoundationZINC OXIDELauren Brooke Cosmetiques LLC4d09907e-ddcd-9d62-e063-6394a90acf3f2026-05-28WarningsExact identifier
application number: M020
GOONGBE Moisture Sun Cushion Mild SPF 50ZINC OXIDEZero to Seven Inc.1e8720b4-5e8b-dc8b-e063-6394a90aad342026-05-27WarningsExact identifier
application number: M020
GOONGBE Fresh Sun Stick Mild SPF 50ZINC OXIDEZero to Seven Inc.1e8727a4-0dc0-19dc-e063-6394a90a82b62026-05-27WarningsExact identifier
application number: M020
Tallow and Sol SUNSCREEN SPF30NON-NANO ZINC OXIDE 20%Guangzhou Shengyanghui Industrial Trading Co., Ltd52c9dc0a-41f7-3e8a-e063-6394a90a8fca2026-05-27WarningsExact identifier
application number: M020
Tallow and SolSUNSCREEN SPF50NON-NANO ZINC OXIDE 25%Guangzhou Shengyanghui Industrial Trading Co., Ltd52cb56cf-f092-9f86-e063-6394a90ac2d32026-05-27WarningsExact identifier
application number: M020
SPF 50 Mineral Sunscreen Face and BodyZINC OXIDEToddle Born Wild, Inc.e97d82fe-cd45-43a5-9c1f-3900025240a12026-05-27WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84509-002-018450900020130 mL in 1 BOTTLE (84509-002-01) 30 ml2024-07-16NoNoCurrent