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 308 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Garnier green labs Pore Perfecting CannaB Serum Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENELOreal USA Products Inc21d9b6dc-6f99-4af4-a838-c762c3fb9e3a2024-01-01WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Hydraphase UV Intense Moisturizer Broad Spectrum SPF 20 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Incad4f45b2-3391-4e32-9744-28838727260c2024-01-01WarningsExact identifier
application number: M020
La Roche Posay New 50 Body and Face SPF 50 Mineral Anthelios Gentle 100 percent mineral UV filters Soft finish with Cell Ox ShieldTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Incc0f7ae46-7161-4d48-9386-007bfafecfd52024-01-01WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios HA Mineral Broad Spectrum SPF 30 Daily Moisturizing SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc7bca5947-88a3-4cb3-a6f2-9fa389d344ef2024-01-01WarningsExact identifier
application number: M020
LOreal Paris Revitalift Miracle Blur Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONEL'Oreal USA Products Inc45eb17f4-6fc0-4e6d-a905-78581175de952024-01-01WarningsExact identifier
application number: M020
LOreal Paris Skin Expert Revitalift Bright Reveal Brightening Day Moisturizer Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc454e4b9a-4ddf-44cf-8ee9-abab6f5744242024-01-01WarningsExact identifier
application number: M020
Kiehls Super Fluid Daily UV Defense SPF 50 plus Anti-Pollution Lightweight Formula for All Skin TypesAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONEL'Oreal USA Products Inc5bbd9e40-3b80-4ecb-b1d4-0110904135342024-01-01WarningsExact identifier
application number: M020
Garnier SkinActive Clearly Brighter AntiSun Damage Daily Moisturizer Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSLATE, OCTISALATE AND OCTOCRYLENELOreal USA Products Inc1d33dc1d-40d5-4a85-8dfe-708bfb9da5382024-01-01WarningsExact identifier
application number: M020
Vichy Laboratoires Aqualia Thermal UV Defense Moisturizer Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc.08bcee1c-399a-4ec8-84cf-b5e83c4fa6652024-01-01WarningsExact identifier
application number: M020
LOreal Paris Skin Paradise Water Infused Tinted Moisturizer Broad Spectrum SPF 19 SunscreenENSULIZOLEL'Oreal USA Products Inc913116de-1abf-4844-8611-1db1b093ad002024-01-01WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios Kids Gentle Broad Spectrum SPF 50 Sunscreen for Face and Body Water Resistant 80 MinutesAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc8a2fd46c-5767-4621-8e69-dd291f9fe5b12024-01-01WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 50 Mineral Daily Tone Correcting Primer Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDEL'Oreal USA Products Inc89b59bd7-9a91-4b99-84e7-996a8b1d499e2024-01-01WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios Clear Skin Face Oil Free Dry Touch Broad Spectrum SPF 60 Sunscreen Water Resistant 80 MinutesAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Ince1310453-1880-43a5-982b-cf9b30cfdc472024-01-01WarningsExact identifier
application number: M020
Kiehls Since 1851 Super Multi Corrective Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENELOreal USA Products Inc733e7853-ab11-4887-83a2-b9d95c1634532024-01-01WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 60 Melt In Sunscreen Milk Broad Spectrum SPF 60 Face and BodyAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONEL'Oreal USA Products Inc53ab6046-058b-4cdf-8e4e-7ce6f52887012023-12-31WarningsExact identifier
application number: M020
CeraVe Developed with Dermatologists Skin Renewing Broad Spectrum SPF 30 DayOCTINOXATE AND ZINC OXIDEL'Oreal USA Products Inc.50542a3b-2ef0-452f-b463-79b41e10d1e02023-12-31WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 50 Tinted Mineral SunscreenTITANIUM DIOXIDEL'Oreal USA Products Inc6d3c5fc5-c818-46c4-8db3-cffcdcd56e062023-12-31WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Sport Anthelios Activewear Broad Spectrum SPF 60 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc071bfb80-d980-4e62-9cd6-96149f1ba04a2023-12-31WarningsExact identifier
application number: M020
Garnier green labs Brightening Serum PineaC Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENELOreal USA Products Inc9302bccb-636d-45f1-8919-9b98c2e685672023-12-31WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 50 Daily Antiaging Primer with SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONEL'Oreal USA Products Inc6b65d6d9-7ff3-4c84-986e-ef180161eadb2023-12-31WarningsExact 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