FDA.reportPublic FDA data

100% MINERAL SUNSCREEN

Product NDC
84484-001
11-digit product format
844840001
Labeler code
84484
Product ID
84484-001_3c4a3b4a-ac90-8ce7-e063-6294a90abe18
Type
HUMAN OTC DRUG
Nonproprietary name
100% MINERAL SUNSCREEN
Dosage form
CREAM
Route
CUTANEOUS
Labeler
Guangzhou Pallas Cosmetics Co.,Ltd.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-08-14
Substance
ZINC OXIDE; TITANIUM DIOXIDE
Active strength
15; 10 g/100mL; g/100mL
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
100% MINERAL SUNSCREEN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE15 g/100mL
TITANIUM DIOXIDE10 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal 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
3c4a3b41-9183-3835-e063-6394a90aea61Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84484-001-01100% MINERAL SUNSCREEN50 mL in 1 BOTTLECREAM501

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 57 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALAT, OCTOCRYLENEOld East Main Co.db876d34-1af9-4e0a-9e9a-32a8b00e94052026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
SunscreenAVOBENZONE, HOMOSALATE,OTISALATE, OCTOCRYLENEOld East Main Co.2ea288fe-815d-4568-9592-55ea428448fa2026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.cea1c223-c9d4-42ac-8c5b-c0ca647d57a12026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
sunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEOld East Main Co.00ee1dc6-b4f3-4ae3-890c-8e37f6d3fe3a2026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.8f4a6a31-2fae-42fe-924f-10237c59e7912026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.ef48288b-533f-4924-ba12-fc8cb83643d42026-03-02WarningsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.e6976bf4-ad77-4953-858f-4a0ec7f4300c2026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.b3d2da09-d9c9-4c27-82fe-a434ece2f0992026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.ba9331ef-3744-4072-80a2-af95c6f7ee052026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.4a0cab2d-3c73-4b0b-b0c4-f72b1a0de1cf2026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.1a53d8d5-e650-4825-8a3b-7cf42c36e3e52026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.086dfda5-9fe7-46b4-9964-4977b86cfdd52026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.ce9a2139-c5c2-43e2-bd51-1f14ace594d92026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
Bask SPF 40 Broad SpectrumAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESurfside Skincare, Inc. dba Bask Suncare49a30877-e39f-46a3-e063-6394a90a8dd22026-03-02WarningsExact identifier
application number: M020
Sunscreen SPF30AVOBENZONE 3% HOMOSALATE 10% OCTOCRYLENE 5%Worthy Promotional Productsf6014a97-12d3-4f42-86de-866a206c6c062026-03-02WarningsExact identifier
application number: M020
2000DL-CL30VSPF30 BS VANILLAEpic Laboratories, LLC02488aad-28be-4ffb-e063-6294a90ad01e2026-03-02WarningsExact identifier
application number: M020
2000DL-CL30TSPF30 BS TROPICALEpic Laboratories, LLC0286f94e-a2e8-b529-e063-6294a90ac08d2026-03-02WarningsExact identifier
application number: M020
2000DL-CL30VSPF30 BS ORIGINALEpic Laboratories, LLC1872eefd-d702-ac9f-e063-6294a90a24ef2026-03-02WarningsExact identifier
application number: M020
JAYSUING White Birch Moisturizing Sunscreen CreamTITANIUM DIOXIDEShantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.4c174691-cc32-b2e4-e063-6294a90a0f732026-03-02WarningsExact identifier
application number: M020
Kypris Pot of Shade Heliotropic Broad Spectrum SPF 30 Sunscreen And PrimerZINC OXIDEKypris Beauty LLCa5d5f7bd-d7bf-4a5c-8530-b9d5d74754c32026-02-27WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84484-001-018448400010150 mL in 1 BOTTLE (84484-001-01) 50 ml2025-08-14NoNoCurrent