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 306 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clove Hill acne safe mineral sunscreen SPF 40ZINC OXIDEClove Hill LLCa06e6393-13c5-48b9-909a-3bdf7d58cad32024-01-22WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF45AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEA-S Medication Solutionsbfb1fdbe-883f-4d1d-9131-a46da98277882024-01-18WarningsExact identifier
application number: M020
LA Bodies Eclipse Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONESAMSON PHARMACEUTICALce3a5ddc-9d4d-4d63-879c-fc4aef9a0a0a2024-01-18WarningsExact identifier
application number: M020
Shunly Zn20 Light MoisturizerZINC OXIDEShunly Skin Care LLCd5710d48-0a4b-49a6-b6b5-9a192afccd2a2024-01-17WarningsExact identifier
application number: M020
Shunly Zn20 Tinted Light MoisturizerZINC OXIDEShunly Skin Care LLCc046eef3-c2d7-42e6-a5ad-98e513fdb4e12024-01-17WarningsExact identifier
application number: M020
Shunly Radiant Translucent SPF 40TITANIUM DIOXIDE, ZINC OXIDEShunly Skin Care LLC20783833-ee7f-4425-b4ab-ab61cda5b2c82024-01-17WarningsExact identifier
application number: M020
LA Bodies Eclipse Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONESAMSON PHARMACEUTICAL48708273-764d-4139-ae06-7cf1a273759c2024-01-17WarningsExact identifier
application number: M020
Shunly Radiant Translucent Tinted SPF 40TITANIUM DIOXIDE, ZINC OXIDEShunly Skin Care LLC1aeb5e05-730c-4c5c-b164-ad9347b0cd932024-01-17WarningsExact identifier
application number: M020
Cerave Developed with Dermatologists Hydrating Sunscreen SPF 50 Body Lightweight, non-greasy feel 3 essential ceramides Mineral SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc4a243c9f-ca88-47fb-8777-1da79c001c732024-01-16WarningsExact identifier
application number: M020
NYX Professional Makeup Bare with Me Daily Moisturizing Primer with Cannabis Sativa Seed Oil SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc7f960d4c-ad09-4dc8-b272-66e4df26ace82024-01-16WarningsExact identifier
application number: M020
MY MEDIC SPF 30 REEF FRIENDLY SUNSCREENHOMOSALATE, TITANIUM DIOXIDE, ETHYLHEXYL SALICYLATE, PHENYLBENZIMIDAZOLE SULFONIC ACIDSled Distribution, LLCec252876-7205-83ec-e053-2a95a90a14632024-01-15WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 50 Tinted Mineral Sunscreen Broad Spectrum SPF 50TITANIUM DIOXIDECosmetique Active Productionfd2541e1-c409-40a8-9e3f-6ff69084ea662024-01-15WarningsExact identifier
application number: M020
Lancome Paris Bienfait UV 50 Plus Broad Spectrum SPF 50 Plus Water Resistant 80 Minutes Super Fluid Facial SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONEL'Oreal USA Products Inc6296fbce-93fe-483e-bd60-6ae228afcaad2024-01-15WarningsExact identifier
application number: M020
LOreal Paris AntiSagging Plus Even Tone Collagen Expert Moisturizer Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEL'Oreal USA Products Incdb483af0-797b-4ef5-b02a-ab9fa1ba87fe2024-01-15WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 50 Tinted Mineral Face Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDEL'Oreal USA Products Incbc72048a-4786-44c2-97ce-0220822816542024-01-15WarningsExact identifier
application number: M020
Caring mill Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFSA Store Inc.0ec201dc-c262-cecd-e063-6394a90a3fd32024-01-12WarningsExact identifier
application number: M020
Caring mill Kids Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE,FSA Store Inc.0ec21837-d4f1-0916-e063-6294a90a21992024-01-12WarningsExact identifier
application number: M020
CERAMIDE LIFT and FIRM EYE SPF 15OXYBENZONE, OCTINOXATEREVLONb22f0c13-0a9c-7d38-e053-2a95a90a0ecd2024-01-12WarningsExact identifier
application number: M020
Elizabeth Arden, Great 8, Moisturizer SPF 35AVOBENZONE, OCTISALATE, HOMOSALATERevlonb1b89565-7292-45eb-e053-2a95a90ae8d02024-01-12WarningsExact identifier
application number: M020
CERAMIDE LIFT and FIRMOCTINOXATE, OXYBENZONE, AVOBENZONE, OCTISALATE, OCTOCRYLENEREVLONb20ae6e9-de6e-0059-e053-2a95a90a57602024-01-12WarningsExact 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