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 265 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MISSHA ALL AROUND VITA C SUNSCREENZINC OXIDE, HOMOSALATE, ETHYLHEXYL SALICYLATE, TITANIUM DIOXIDEAble C&C Co., Ltd.1a7ec673-328a-8924-e063-6294a90a2f3d2024-12-05WarningsExact identifier
application number: M020
(Re)Setting Refreshing Mist SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLCd4d8f28d-cb00-298d-e053-2995a90a10eb2024-12-05WarningsExact identifier
application number: M020
KEYS SOULCARE DAILY MOISTURIZER BROAD SPECTRUM SPF30 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc2ba71f81-54d0-4955-9bae-2b6e35c9c35f2024-12-05WarningsExact identifier
application number: M020
Cay Skin Isle Glow Body SPF 45AVOBENZONE, OCTISALATE, OCTOCRYLENECay Skin, Inc.db5f6bad-65ae-2b05-e053-2a95a90a85692024-12-05WarningsExact identifier
application number: M020
Cay Skin Isle Glow Face SPF 45AVOBENZONE, OCTISALATE, OCTOCRYLENECay Skin, Inc.d91bba06-fd9b-3eb5-e053-2995a90a61242024-12-05WarningsExact identifier
application number: M020
Whoa Glow broad spectrum spf 30 sunscreen Sheer Bronze shimmerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc65de9491-8804-4e3b-90a7-9b253e34b7d32024-12-05WarningsExact identifier
application number: M020
Whoa Glow broad spectrum spf 30 sunscreen Sheer Champagne shimmer sunlightAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc499e5352-fcc4-4434-96f2-4375816991c92024-12-05WarningsExact identifier
application number: M020
Cay Skin Isle Sheen Sunstick SPF 35AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECay Skin, Inc.288c3aeb-01b2-ce39-e063-6394a90ad04a2024-12-05WarningsExact identifier
application number: M020
Cay Skin MoBay Mineral Sunscreen Drops SPF 30ZINC OXIDECay Skin, Inc.288d5456-98f3-a998-e063-6294a90a83662024-12-05WarningsExact identifier
application number: M020
Solar Moisturizer SPF 30OCTINOXATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENEAllure Labs, LLCef4d54bf-25f5-4261-9d3d-c42b0d8922752024-12-05WarningsExact identifier
application number: M020
Clear Clear Zinc Solar Protection SPF 30ZINC OXIDEAllure Labs, LLC79a3c8e2-c4f2-4c00-8e94-494654ae91a22024-12-05WarningsExact identifier
application number: M020
LAB SERIES DAY RESCUE DEFENSE BROAD SPECTRUM SPF 35AVOBENZONE, HOMOSALATE, OCTISALATE, AND OXYBENZONEAramis Inc.8b206b6d-92e4-48bc-a40c-93ffdd6355352024-12-05WarningsExact identifier
application number: M020
Kids Broad Spectrum SPF 35ZINC OXIDEAllure Labs, LLCb72caf9b-46df-f30c-e053-2995a90a9b6d2024-12-05WarningsExact identifier
application number: M020
CBD Blue Light Defense SPF 30ZINC OXIDEAllure Labsb63b99af-2ddb-3535-e053-2a95a90a65d52024-12-05WarningsExact identifier
application number: M020
AHAVA CC SPF 30AVOBENZONE, ENSULIZOLE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEAHAVA - Dead Sea Laboratories Ltd2fa6249a-9614-455c-8e07-9b829f3b0c222024-12-04WarningsExact identifier
application number: M020
EGF FGF DNA UV SHIELDETHYLHEXYL METHOXYCINNAMATE, TITANIUM DIOXIDE, ETHYLHEXYL SALICYLATEDermaesthetics Inc.13e2630d-9915-4287-91fd-deb6721501312024-12-04WarningsExact identifier
application number: M020
SUNSCREEN 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.e98c3b64-edcb-16c7-e053-2a95a90a8a0e2024-12-04WarningsExact identifier
application number: M020
Sun ,Bug Handsfree 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.f8f29aec-935f-e828-e053-6394a90a570a2024-12-04WarningsExact identifier
application number: M020
sunscreen 01AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.e9e3ecc1-3f13-1d0e-e053-2a95a90ac7f82024-12-04WarningsExact identifier
application number: M020
MISSHA M Perfect Cover BB No 13ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATEAble C&C Co., Ltd.95846b5e-5b72-26bc-e053-2a95a90ae0f72024-12-04WarningsExact 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