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 315 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SERIOUS SKINCARE SERIOUS C3 PLASMA BIO TECHNOLOGY C VITAMIN C ESTER PROTECTIVE DAYTIME BROAD SPECTRUM MOISTURIZER SPF 30AVOBENZONE, OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONEFlageoli Limited4d11cc46-3942-1561-e054-00144ff8d46c2023-12-12WarningsExact identifier
application number: M020
ACTIVE ARGAN 365 SPF 30 BROAD SPECTRUM ACTIVATED ARGAN COMPLEXZINC OXIDESIBORG LLC9c4897f8-8fcb-4a0f-b42e-f582e2934f022023-12-12WarningsExact identifier
application number: M020
Byoma Moisturizing Gel Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATEENGLEWOOD LAB, INC.f63fe60f-9863-1dfb-e053-2a95a90a90a52023-12-12WarningsExact identifier
application number: M020
MD Mineral BB Creme Broad Spectrum SPF 50 Water Resistant 80 MinTITANIUM DIOXIDE, ZINC OXIDEENGLEWOOD LAB, INC.5742da4b-6713-4de9-8ab8-b2bf2983371a2023-12-12WarningsExact identifier
application number: M020
restorsea Rejuvenating Day SPF 30 Broad Spectrum UVA UVB with Vibransea ComplexZINC OXIDERESTORSEA INC80ed7b28-16e0-4c9a-8e36-9d32ca3ddb9a2023-12-12WarningsExact identifier
application number: M020
ReVive Fermitif Neck Renewal SPF 15AVOBENZONE, OCTINOXATE, OCTOCRYLENE, OXYBENZONEGurwitch Products, LLCde54d4ff-f9b4-4a12-95ea-fc2b61bee1c32023-12-12Exact identifier
application number: M020
Laura Mercier Flawless Skin Daily Face Shield SPF 40OCTINOXATE, TITANIUM DIOXIDEGurwitch Products, LLCf86729cd-682f-47b2-9bfa-1113721bfec02023-12-12WarningsExact identifier
application number: M020
Boscia BB SPF 27 PATITANIUM DIOXIDEBoscia LLC5dc86c0b-c340-4643-a174-a6b4c0826ca92023-12-12WarningsExact identifier
application number: M020
Dr.Denese SPF 30 Defense DayZINC OXIDE, OCTINOXATESkinScience Labs, Inc511dd97b-0f83-4ce9-8bfd-fa385f0dc8aa2023-12-12WarningsExact identifier
application number: M020
Boscia Daily Hydration SPF 15 Broad Spectrum For Normal To Oily SkinAVOBENZONE, OCTINOXATEBoscia LLC0c987cb9-7049-44b9-9935-647b0411a7342023-12-12WarningsExact identifier
application number: M020
Boscia BB Broad Spectrum SPF 27 PA Self Adjusting ShadeTITANIUM DIOXIDE, ZINC OXIDEBoscia LLC82a23aab-404f-46bb-afaa-8ba9b9bdbefd2023-12-12WarningsExact identifier
application number: M020
Boscia Restorative Day Moisture Broad Spectrum SPF 15 For Dry SkinAVOBENZONE, OCTINOXATEBoscia LLC657b04c6-d15b-470b-92e6-e59ed7e8b1162023-12-12WarningsExact identifier
application number: M020
Cellular Laboratories De-Aging Sunscreen Broad Spectrum SPF 50 PlusHOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENEMarket Americac1898e00-05f1-4e28-9fa8-8cda1b1785952023-12-12WarningsExact identifier
application number: M020
Boscia BB BRONZE Broad Spectrum SPF 27 PA Self-Adjusting ShadeTITANIUM DIOXIDE, ZINC OXIDEBoscia LLC5f5fb9f5-00be-420a-b19a-b753c45f9a882023-12-12WarningsExact identifier
application number: M020
Boscia Self-Defense Vital Antioxidant Moisture Broad Spectrum SPF 30AVOBENZONE, OCTINOXATEBoscia LLC7d948951-598a-4a38-94a2-d357ee7f4d1e2023-12-12WarningsExact identifier
application number: M020
Restorative Day Moisture SPF 15OCTINOXATE, AVOBENZONEBoscia LLC01f17133-7f29-4f8e-a52c-c4466e4abefc2023-12-12WarningsExact identifier
application number: M020
3LAB Aqua BB SPF 40 BROAD SPECTRUM 03TITANIUM DIOXIDE3LAB, Inc.8a42a9d8-b9c6-45fb-8264-15f36e2765f02023-12-12WarningsExact identifier
application number: M020
3LAB Hydra Day SPF 20 Broad Spectrum Water-Based SunscreenOCTINOXATE, OCTISALATE, AVOBENZONE3LAB, Incd539b851-c4b2-40a2-9562-e3a95a86b7442023-12-12WarningsExact identifier
application number: M020
3LAB PERFECT Lite Sunscreen SPF 30 Broad SpectrumTITANIUM DIOXIDE, ZINC OXIDE3LAB, Inc3052af3f-8923-47bc-be6e-17396275363a2023-12-12WarningsExact identifier
application number: M020
Isa SunGuard SPF 30ZINC OXIDE, TITANIUM DIOXIDEIsagenix International, LLCabe1e345-6ea2-43b3-8613-b5b5e04c87b72023-12-12WarningsExact 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