SANTO REMEDIOS Piel Eterna Radiance Sunscreen Primer SPF-42

Product NDC
81352-321
11-digit product format
813520321
Labeler code
81352
Product ID
81352-321_09769ae3-d18d-e2dd-e063-6294a90a1f64
Type
HUMAN OTC DRUG
Nonproprietary name
TITANIUM DIOXIDE, ZINC OXIDE
Dosage form
LOTION
Route
TOPICAL
Labeler
SANTO REMEDIO LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-03-21
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
60; 80 mg/mL; mg/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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
SANTO REMEDIOS Piel Eterna Radiance Sunscreen Primer SPF-42
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE60 mg/mL
ZINC OXIDE80 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
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
82d210bc-b7ca-4d74-be58-85f175a75058Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81352-321-00SANTO REMEDIOS Piel Eterna Radiance Sunscreen Primer SPF-4250 mL in 1 TUBELOTION502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81352-321SANTO REMEDIOS PIEL ETERNA RADIANCE SUNSCREEN PRIMER SPF-42 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [SANTO REMEDIO LLC]2Current NDC, Legacy NDC, 1 package rows20231106_82d210bc-b7ca-4d74-be58-85f175a75058.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 203 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Face Reality Brilliant Defense Sunscreen SPF 50OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEFace Reality,LLC618f58b7-2f29-4dff-8c3a-4fdbe1eb8ce42025-07-29WarningsExact identifier
application number: M020
Face Reality Power Mineral Sunscreen SPF 50ZINC OXIDEFace Reality,LLC8c502e11-6e97-46d6-8775-1bbafaeb18f82025-07-29WarningsExact identifier
application number: M020
SPF30 unseen sunscreen stick 01AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.3afa3bdb-e924-55c1-e063-6394a90af3522025-07-28WarningsExact identifier
application number: M020
Neutrogena Mineral Invisible Daily Defense Face Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLC003123d2-9675-fdd2-e063-6294a90a01302025-07-28WarningsExact identifier
application number: M020
Neutrogena Mineral Ultra Sheer Face SPF 70TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLC20e0badf-fe25-1d27-e063-6294a90a7cfe2025-07-28WarningsExact identifier
application number: M020
Basin Santas Cookies SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3b016dcf-fb74-916f-e063-6294a90a683d2025-07-28WarningsExact identifier
application number: M020
Basin Vanilla SPF 30 Broad Spectrum Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONERetail Concepts of Minnesota, Inc.3b01c6a4-2230-c83e-e063-6294a90aa66d2025-07-28WarningsExact identifier
application number: M020
Basin Peppermint Swirl SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3b022c84-00a5-ece9-e063-6294a90a09bd2025-07-28WarningsExact identifier
application number: M020
Basin Winter Berry Blast SPF15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3b02c3f2-a43a-0d29-e063-6394a90a76b52025-07-28WarningsExact identifier
application number: M020
KARA VITA Moisturizing Sunscreen with DNArescueOXYBENZONE, AVOBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATEKara Vita, Inc.2130e9ac-5946-4b00-94d0-a78fd1ccfd132025-07-25WarningsExact identifier
application number: M020
78 x 36 SPF 30 ActiveZINC OXIDEDermazone LLC96a8aacc-5c2f-410a-8fb4-8b3bc0f81e552025-07-25WarningsExact identifier
application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 01N LightOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L2ccf4e45-4cec-417d-9f4c-28f376025f1d2025-07-25WarningsExact identifier
application number: M020
celazome Moisturizing SPF 30 ActiveOXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATEDermazone LLC5ec1510d-1465-4849-9e23-f16e11ff0e652025-07-25WarningsExact identifier
application number: M020
Skinuva Scar plusZINC OXIDEMD Medical Designs, Inc.5fcad8c3-a268-4966-b0a9-6cd2c7afd3b72025-07-25WarningsExact identifier
application number: M020
celazome Moisturizing SPF 29 Active with DNArescueOXYBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATEDermazone LLC99fb90ca-6527-459b-8af2-627ea9abe11b2025-07-25WarningsExact identifier
application number: M020
The Men Pen TALLOW GUARD SPF 30 PREMIUM ZINC SUNSCREENZINC OXIDEGuangzhou Haishi Biological Technology Co., Ltd.3aa93f52-ec01-01c2-e063-6294a90a93472025-07-24WarningsExact identifier
application number: M020
Mineral Suscreen SPF 30ZINC OXIDE 19.0%Vivant Pharmaceuticals, LLC3aadb658-d12d-ae8d-e063-6394a90a64962025-07-24WarningsExact identifier
application number: M020
SunscreenTITANIUM DIOXIDE 6.8%Baxter of California, LLC146030bc-2bf4-25ea-e063-6294a90a46132025-07-24WarningsExact identifier
application number: M020
Leg and Body Makeup Broad Spectrum SPF 25OCTISALATE 3.2% OCTOCRYLENE 6%Baxter of California, LLC14adc826-6e9d-382a-e063-6294a90a5d792025-07-24WarningsExact identifier
application number: M020
Tiege Hanley AM Morning Facial Moisturizer with SPF 20AVOBENZENE, OCTINOXATE, OCTOCRYLENETIEGE HANLEY, Inc22086cd8-2126-120e-e063-6394a90a561e2025-07-24WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81352-321-008135203210050 mL in 1 TUBE (81352-321-00) 50 ml2022-03-210000-00-00NoNoCurrent