FDA.reportPublic FDA data

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 284 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Topco Topcare Everyday Mineral Sunscreen Continuous SPF 30ZINC OXIDETOPCO ASSOCIATES LLCf71e019b-392a-f8eb-e053-6394a90a871e2024-10-15WarningsExact identifier
application number: M020
TOPCARE EVERYDAY SPORT SPF 70 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONETOPCO ASSOCIATES LLCa5b06600-f2b0-6d9b-e053-2995a90a59f02024-10-15WarningsExact identifier
application number: M020
TopCare Everyday Ultra Protection Sun SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETOPCO ASSOCIATES LLCf41d4c46-7998-afe6-e053-2995a90ab3612024-10-15WarningsExact identifier
application number: M020
TOPCO TOPCARE EVERYDAY BABY PROTECTION SUN SPF 50OCTISALATE, ZINC OXIDETOPCO ASSOCIATES LLCf71c9060-3daf-e1be-e053-6294a90a4f912024-10-15WarningsExact identifier
application number: M020
MINERAL SUNSCREEN SPF 50ZINC OXIDE, TITANIUM DIOXIDETOPCO ASSOCIATES LLCbfe076fa-f21f-2c46-e053-2a95a90acee42024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Mineral Sunscreen StickZINC OXIDEH.E.B.f58f0199-bf22-2197-e053-2995a90ae64f2024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Kids Blue Mineral Sunscreen Stick Berry ScentedZINC OXIDEH.E.B.f58d328c-8b30-b4d4-e053-2a95a90adb592024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Kids Purple Mineral Sunscreen Stick Grape ScentedZINC OXIDEH.E.B.f58ed2f9-67c3-ce91-e053-2995a90a12292024-10-15WarningsExact identifier
application number: M020
HEB Shimmer Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf5930029-4c96-2576-e053-2995a90a7bed2024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Birthday Cake SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf5a3313e-4935-1ce3-e053-2a95a90a6ad12024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 White Gardenia Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf5b6caf2-ebff-79fb-e053-2995a90ac2f82024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 For Men SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE,OCTOCRYLENEH.E.Bf59461e3-9521-6a7b-e053-2a95a90a73b82024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Pink Peony SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE,OCTOCRYLENEH.E.Bf5a2c266-6fc9-21ae-e053-2995a90aec0e2024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Pink Peony Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf5b7172a-b8fc-0d11-e053-2a95a90a9f732024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Peach Bellini Scented Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf5cbac04-361f-9226-e053-2995a90a2d7b2024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Cucumber Water Scented Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf5d933cf-3461-8b03-e053-2a95a90ad79f2024-10-15WarningsExact identifier
application number: M020
HEB Oil Free Facial Moisturizer with Sunscreen Broad Spectrum SPF 15AVOBENZONE, OCTISALATE, OCTOCRYLENEH.E.Bf6ce4ea0-d92f-368c-e053-6294a90a2a812024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 White Gardenia SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE,OCTOCRYLENEH.E.Bf5a2702c-5451-58a1-e053-2a95a90adb8e2024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Strawberry Daquiri Scented Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf5cb5f9a-6691-37c3-e053-2a95a90a9af02024-10-15WarningsExact identifier
application number: M020
HEB SPF 50 Rosewater Scented Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf5db7ec6-0e9b-7044-e053-2a95a90a1e482024-10-15WarningsExact 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