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 140 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 21N PACK OF 2OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.3483e4fa-883b-fb9c-e063-6394a90adcc42025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 23W PACK OF 2OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.3483dd31-417b-01ba-e063-6294a90a83a82025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 27C PACK OF 2OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.3483e998-6122-fb84-e063-6394a90a159f2025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 28NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.c96e691a-99e1-4cb4-aebf-7444f4a6865f2025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 33NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.ab1c8e9e-fd8f-473e-8930-625706e8e9d62025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 29WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.17073264-ec02-4801-841d-86778debd8c42025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 41NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.caee5c88-1907-41c1-987e-5bc544267dca2025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 33WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.973b70f1-ee59-4dd9-aca3-432d721204ab2025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 27WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.208fe03e-384b-4599-a4d0-a553fba306da2025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 35NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.279258dd-b3fa-47be-8540-66bd9c879fc52025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 47NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.c2ad2a5e-f8fe-41b3-8b0f-9981c337ec5c2025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 31NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.4206b607-5c26-4c9d-ade7-58c9740cdbe82025-12-09WarningsExact identifier
application number: M020
L Bri CC DD Color Correcting Daily Defense Sunscreen SPF 30 MediumOCTOCRYLENE, ZINC OXIDEL'BRI Health & Beauty949a2796-717c-4820-ae09-2636e3dd6e3d2025-12-09WarningsExact identifier
application number: M020
L Bri CC DD Color Correcting Daily Defense Sunscreen SPF 30 Medium DarkOCTOCRYLENE, ZINC OXIDEL'BRI Health & Beautyf9bbc6d3-eb50-4953-8dba-732094b4c7c42025-12-09WarningsExact identifier
application number: M020
Safe Sea SPF 50HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONENIDARIA TECHNOLOGY LTD53df3126-1136-490a-b339-5876ce89499e2025-12-09WarningsExact identifier
application number: M020
Safe Sea SPF 50 kidsHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONENIDARIA TECHNOLOGY LTD3fa04557-2bc1-4eb4-aed8-eacc791896132025-12-09WarningsExact identifier
application number: M020
Safe Sea SPF 40OCTOCRYLENE, HOMOSALATE, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANENIDARIA TECHNOLOGY LTDc900b88b-1de1-4df9-af84-d9001e1d47642025-12-09WarningsExact identifier
application number: M020
StriVectin ANTI-WRINKLE GLOWFECTOR SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEStriVectin Operating Company, Inc.ed357e76-54a1-66bd-e053-2a95a90a1e2a2025-12-09WarningsExact identifier
application number: M020
Non-tinted Physical Block SunscreenTITANIUM DIOXIDE, ZINC OXIDETucson Acne Clinic30dd2f6b-5dcc-b081-e063-6394a90ae5f12025-12-09WarningsExact identifier
application number: M020
Tinted Physical Block SunscreenTITANIUM DIOXIDE, ZINC OXIDETucson Acne Clinic30dc6e23-ecca-ed0b-e063-6294a90a79512025-12-09WarningsExact 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