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 82 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Blue Lizard Baby SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories32d6e04a-fa30-ba48-e063-6394a90a1bbf2026-01-12WarningsExact identifier
application number: M020
Blue Lizard Kids SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories2f780daa-4c91-5a68-e063-6394a90afd412026-01-12WarningsExact identifier
application number: M020
Blue Lizard Sensitive SPF 50ZINC OXIDECrown Laboratories99839894-9695-2cd1-e053-2995a90acba62026-01-12WarningsExact identifier
application number: M020
Blue Lizard SPF 15 Lip BalmZINC OXIDECrown Laboratories1bf8fb7e-9d5b-86d4-e063-6294a90afddc2026-01-12WarningsExact identifier
application number: M020
Blue Lizard Kids SPF 50ZINC OXIDECrown Laboratories9983563c-1e63-0748-e053-2a95a90a971e2026-01-12WarningsExact identifier
application number: M020
Blue Lizard Baby SPF 50ZINC OXIDECrown Laboratories9948f5b8-43bd-1c99-e053-2a95a90a61212026-01-12WarningsExact identifier
application number: M020
Blue Lizard Sheer SPF 50 SunscreenZINC OXIDECrown Laboratories3368f1cb-c341-e886-e063-6394a90a9b7c2026-01-12WarningsExact identifier
application number: M020
Blue Lizard Sport SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories2f3844d8-0367-aad9-e063-6294a90a1fce2026-01-12WarningsExact identifier
application number: M020
Blue Lizard Sheer Face SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories30cd79da-2f25-a42a-e063-6394a90a83322026-01-12WarningsExact identifier
application number: M020
ACCOJE PROTECTIVE AIR-FIT MINERAL SUNSCREENTITAMIUN DIOXIDE, ZINC OXIDEUCL Co., Ltd.4837b4f6-ada9-801a-e063-6294a90a85472026-01-12WarningsExact identifier
application number: M020
Intellishade Original SPF 45OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDERevision, LLCe213a681-eb22-69c0-e053-2995a90a899e2026-01-12WarningsExact identifier
application number: M020
GINZING SPF 40 ENERGY-BOOSTING TINTED MOISTURIZER BROAD SPECTRUM SPF 40 SHEER TINT RELEASEHOMOSALATE,OCTINOXATE,OCTISALATE, AND ZINC OXIDEORIGINS NATURAL RESOURCES INC.48393640-4b97-04de-e063-6294a90aa6a62026-01-12WarningsExact identifier
application number: M020
Hale and Hush Broad Spectrum SPF 30 SPF 30ZINC OXIDEEclectic Solutions LLC0530904f-b02c-d8cf-e063-6294a90aa5a72026-01-12WarningsExact identifier
application number: M020
Minori Daily Mineral Face Sunscreen Broad Spectrum SPF 30ZINC OXIDEMinori Inc.1d4e2654-1638-0d01-e063-6394a90af3032026-01-12WarningsExact identifier
application number: M020
LUXURY BODY RITUAL HYDRATING SPF 30ZINC OXIDEJANE STREET LLC15e9d688-f226-1a19-e063-6394a90ab9062026-01-12WarningsExact identifier
application number: M020
BROAD SPECTRUM SPF50 SPF 50AVOBENZONE, HOMOSALATE OCTISALATE,NAKED SUNDAYS PTY LTD0426b1e9-063b-c1e6-e063-6294a90a25542026-01-11WarningsExact identifier
application number: M020
SPF30 MINERAL SUNSCREEN MOUSSEZINC OXIDEAopline Biotechnology (Guangzhou) Co., Ltd.48031a0f-c2ed-5424-e063-6294a90ad0ff2026-01-10WarningsExact identifier
application number: M020
SPF 30 MINERAL WHIPPED CREAMS SHIMMERZINC OXIDEAopline Biotechnology (Guangzhou) Co., Ltd.48037a05-722e-4231-e063-6294a90ac51f2026-01-10WarningsExact identifier
application number: M020
ODLUMIVIE Tinted Mineral SunscreenZINC OXIDE,TITANIUM DIOXIDEGuangzhou Meijiao Medical Biotechnology Co., Ltd.480d6e65-f6dc-d2a5-e063-6294a90a24a12026-01-10WarningsExact identifier
application number: M020
Cloud Brush On Sunscreen Clear Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFUTURE 8 LLC9922f132-f6a5-41ca-847a-936b20bf17162026-01-09WarningsExact 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