FDA.reportPublic FDA data

PIPA SKIN CARE SUN-SATIONAL

Product NDC
84178-002
11-digit product format
841780002
Labeler code
84178
Product ID
84178-002_47e23c78-47b3-7a49-e063-6394a90a4e81
Type
HUMAN OTC DRUG
Nonproprietary name
SPF 30
Dosage form
CREAM
Route
CUTANEOUS
Labeler
EVI LABS
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-11-06
Substance
ZINC OXIDE
Active strength
6.25 g/50g
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
PIPA SKIN CARE SUN-SATIONAL
Brand name suffix
Mineral Sunscreen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE6.25 g/50g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
258b7b7c-a3f2-172c-e063-6394a90aec6aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84178-002-01PIPA SKIN CARE SUN-SATIONALMineral Sunscreen50 g in 1 BOTTLE, PLASTICCREAM502
84178-002-01PIPA SKIN CARE SUN-SATIONALMineral Sunscreen1 in 1 BOXCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84178-002PIPA SKIN CARE SUN-SATIONAL MINERAL SUNSCREEN (SPF 30) CREAM [EVI LABS]1Current NDC, 2 package rows20241106_258b7b7c-a3f2-172c-e063-6394a90aec6a.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 112 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Brightening Primer SPF 20TITANIUM DIOXIDE AND ZINC OXIDEColoresciencea42d6761-47cd-4c9b-9656-64e37e0656392025-12-17WarningsExact identifier
application number: M020
Avail Body with SunscreenHOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEEmeis Cosmetics Pty Ltd4bb39ea1-f948-4357-b425-0cafd454ce302025-12-17WarningsExact identifier
application number: M020
Bronzing Primer SPF 20TITANIUM DIOXIDE AND ZINC OXIDEColoresciencef749af07-0fcd-4376-be62-7c078b3e7eb62025-12-17WarningsExact identifier
application number: M020
Miffy Tone Perfecting SPF CushionHOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDERBGROUP Co., Ltd98a2906d-61e2-4627-a695-a20f10872f9a2025-12-16WarningsExact identifier
application number: M020
Dear Sun Tone Perfecting SPF CushionHOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDERBGROUP Co., Ltd80748647-e0ea-46dc-8ee2-a0ad77c4b19d2025-12-16WarningsExact identifier
application number: M020
SUNSCREEN StickZINC OXIDE 15%, TITANIUM DIOXIDE 8%, HOMOSALATE 6%Foshan Sugar Max Cosmetics CO.,Ltd460e1038-30f0-a6e4-e063-6394a90ad5342025-12-16WarningsExact identifier
application number: M020
SUNSCREEN SPRAY150mlZINC OXIDE 15%, TITANIUM DIOXIDE 6%, HOMOSALATE 5%, OCTISALATE 4%Foshan Sugar Max Cosmetics CO.,Ltd460ead6c-dd44-e320-e063-6294a90a2b642025-12-16WarningsExact identifier
application number: M020
Sunscreen CreamZINC OXIDE 12%,TITANIUM DIOXIDE 8%, HOMOSALATE 12%, OCTISALATE4.5%,PHENYLBENZIMIDAZOLE SULFONIC ACID 3.5%Foshan Sugar Max Cosmetics CO.,Ltd460f0ca0-9440-9a6e-e063-6394a90a33b32025-12-16WarningsExact identifier
application number: M020
Unseen Sunscreen Lip Protector SPF 30OCTOCRYLENE, AVOBENZONE, HOMOSALATE, OCTISALATESupergoop LLCdb12a89f-5fef-1b2a-e053-2a95a90a56f92025-12-16WarningsExact identifier
application number: M020
Tinted Mineral SunscreenZINC OXIDENatur LLC365f3c48-15a6-2d32-e063-6394a90aad782025-12-16Exact identifier
application number: M020
Non Tinted Mineral SunscreenZINC OXIDENatur LLC365fffa2-b846-7dd3-e063-6394a90a47cb2025-12-16Exact identifier
application number: M020
Tinted Replenishing Daily ProtectionZINC OXIDENatur LLC36603550-9c3d-5e33-e063-6394a90adfc92025-12-16Exact identifier
application number: M020
Shield And Protect TintedZINC OXIDETRILOGY LABORATORIES, LLC37f00e51-1123-c04c-e063-6294a90abed82025-12-16Exact identifier
application number: M020
Shield And ProtectZINC OXIDETRILOGY LABORATORIES, LLC37f09dd5-084f-3c80-e063-6394a90a7a532025-12-16Exact identifier
application number: M020
Non Tinted Facial Mineral ProtectantTITANIUM DIOXIDE, ZINC OXIDEEUROPEAN SKIN AND MASSAGE STUDIO3766496f-231c-f98c-e063-6294a90aae082025-12-16Exact identifier
application number: M020
Tinted Facial Mineral ProtectantTITANIUM DIOXIDE, ZINC OXIDEEUROPEAN SKIN AND MASSAGE STUDIO3766b0d8-20e6-a227-e063-6294a90af4da2025-12-16Exact identifier
application number: M020
Non-Tinted Mineral SunscreenZINC OXIDEWECARE FRISCO PLLC37515807-e29a-3916-e063-6394a90a1ffd2025-12-16Exact identifier
application number: M020
Tinted Mineral Sunscreen Broad Spectrum SPF 40TITANIUM DIOXIDE, ZINC OXIDEWECARE FRISCO PLLC374f866d-eb52-61e3-e063-6394a90a77c72025-12-16Exact identifier
application number: M020
Tinted Lip ProtectionTITANIUM DIOXIDE, ZINC OXIDEWECARE FRISCO PLLC3750c23d-c3f8-fac3-e063-6394a90a135e2025-12-16Exact identifier
application number: M020
Non-Tinted Mineral Sunscreen Broad Spectrum SPF 40ZINC OXIDEWECARE FRISCO PLLC374fe86e-cbe8-f911-e063-6294a90a96002025-12-16Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
84178-002-01841780002011 BOTTLE, PLASTIC in 1 BOX (84178-002-01) / 50 g in 1 BOTTLE, PLASTIC2024-11-06NoNoCurrent