FDA.reportPublic FDA data

Aloe UP SPF 33 Mineral

Product NDC
61477-231
11-digit product format
614770231
Labeler code
61477
Product ID
61477-231_46b40452-68f5-68f0-e063-6394a90a14fd
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Aloe Care International, LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-05-21
Substance
ZINC OXIDE
Active strength
20 g/100g
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
Aloe UP SPF 33 Mineral
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE20 g/100g

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
35aa6196-682d-8f32-e063-6394a90aad99Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61477-231-01Aloe UP SPF 33 Mineral30 g in 1 TUBELOTION304
61477-231-03Aloe UP SPF 33 Mineral89 g in 1 TUBELOTION894
61477-231-11Aloe UP SPF 33 Mineral3785 g in 1 CONTAINERLOTION37854

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 126 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medicated Herbal Lip BalmMENTHOLEarth Mama Angel Baby LLC1cc2391e-6a7a-609c-e063-6394a90a63052024-10-01WarningsExact identifier
application number: M017
CVS Health Lidocaine Plus Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLNATURAL ESSENTIALS, INC.1adb9b74-4a01-4461-b845-f3aedcb3f8102024-10-01WarningsExact identifier
application number: M017
CircataCAPSAICINPureTek Corporationb67161d7-cc5c-e971-e053-2995a90acbe72024-10-01WarningsExact identifier
application number: M017
MenticamCAMPHOR,MENTHOL, METHYL SALICYLATEPureTek Corporationffea2e97-777f-434b-e053-6394a90a3a632024-10-01WarningsExact identifier
application number: M017
Herb Street Sore Muscle ReliefMETHYL SALICYLATEBalassa Laboratories Inc.e43943c2-d4cd-44c5-a0ff-403a8d42860f2024-10-01WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONEKroger Company68dab606-0385-48b7-9a7b-a2cf83d203932024-09-29WarningsExact identifier
application number: M017
kirkland signature hydrocortisone plus maximum strengthHYDROCORTISONECostco Wholesale Company481341c5-db1f-43fb-aed7-f40495a4eab82024-09-29WarningsExact identifier
application number: M017
Care One hydrocortisone maximum strengthHYDROCORTISONEAmerican Sales Company32593229-d0ac-4d6c-831a-089fc6e761522024-09-29WarningsExact identifier
application number: M017
good sense anti itchHYDROCORTISONEL. Perrigo Companyb7a896cc-1d78-45c0-a73e-aa1e117f7d3b2024-09-29WarningsExact identifier
application number: M017
Topcare HydrocortisoneHYDROCORTISONETopco Associates LLCb7362f21-f1a3-4edc-b5b6-a16680e05df32024-09-29WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONEH E B412ca2d1-064b-4438-aee1-fcb5cf27c7db2024-09-29WarningsExact identifier
application number: M017
Topcare AntibioticNEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDETopco Associates LLC8c349cac-20e1-4600-9b0a-fcfe929551c52024-09-26WarningsExact identifier
application number: M017
good sense anti itchHYDROCORTISONEA-S Medication Solutions072dd455-24a5-4a44-aaef-d3e137d005a62024-09-26WarningsExact identifier
application number: M017
SYREN Intimate ReliefLIDOCAINE HYDROCHLORIDEIcon Health Science57d5a080-3583-4510-e053-2a91aa0ad5892024-09-25WarningsExact identifier
application number: M017
AOSI HEALTHCAREHYDROCORTISONENantong Health & Beyond Hygienic Products Inc.f4db90ad-dd62-44f1-9655-2614ed36581e2024-09-25WarningsExact identifier
application number: M017
AOSI HEALTHCARE BURNLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDENantong Health & Beyond Hygienic Products Inc.a28b920c-0bb8-4b5a-addd-26ea164e036e2024-09-25WarningsExact identifier
application number: M017
anti itchDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEKroger Company067e718a-ec0b-4895-8f9f-82d64ab4c7b42024-09-24WarningsExact identifier
application number: M017
topcare anti itchDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATETopco Associates LLCe0fb332a-2903-41ef-b35b-7cd3a74cff992024-09-24WarningsExact identifier
application number: M017
equaline anti itchHYDROCORTISONEUnited Natural Foods, Inc. dba UNFI83cd9f60-a4c4-4dea-97a7-cd96aade9e882024-09-24WarningsExact identifier
application number: M017
good sense itch reliefDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEL. Perrigo Company162fe0a3-3995-4e6f-94ed-f839b2b0c80e2024-09-24WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
61477-231-016147702310130 g in 1 TUBE (61477-231-01) 30 g2025-05-21NoNoCurrent
61477-231-036147702310389 g in 1 TUBE (61477-231-03) 89 g2025-05-21NoNoCurrent
61477-231-11614770231113785 g in 1 CONTAINER (61477-231-11) 3785 g2025-05-21NoNoCurrent