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 134 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dermachange Arthritis ReliefTROLAMIN SALICYLATEPrivate Beauty Label and Wellness12dbfa50-1b97-f988-e063-6394a90a662c2024-03-04WarningsExact identifier
application number: M017
AnalgesicMENTHOLSafetec of America, Inc.b0f4010c-995f-40e1-aa40-92760e697a612024-03-02WarningsExact identifier
application number: M017
Icy Hot Advanced ReliefCAMPHOR AND MENTHOLChattem, Inc.9979ff36-415b-44e4-bb10-6bf682cd00f92024-03-01WarningsExact identifier
application number: M017
Amish Origins Pain Relieving Menthol 8%MENTHOLAmish Origins Management, LLC5051b650-18a4-481e-a8d7-d41d4ae51efd2024-02-29WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONETRIFECTA PHARMACEUTICALS USA LLC2999fecb-cb15-4023-ade4-ab5822b094d52024-02-29WarningsExact identifier
application number: M017
Amish Origins Pain Relieving Menthol 8MENTHOLAmish Origins Management, LLCaaad56d5-6737-4edc-af0e-8e207695c0ec2024-02-29WarningsExact identifier
application number: M017
Amish Origins Pain Relieving Menthol 8%MENTHOLAmish Origins Management, LLCb120404f-5a07-4182-bb50-d943418622da2024-02-29WarningsExact identifier
application number: M017
Amish Origins Topical Analgesic Camphor 2%CAMPHOR (SYNTHETIC)Amish Origins Management, LLC437491ca-60ff-4508-b408-f97e7152f6382024-02-29WarningsExact identifier
application number: M017
Amish Origins Topical Analgesic Camphor 2%CAMPHOR (SYNTHETIC)Amish Origins Management, LLCffe15aed-ea90-4db8-aace-d691a81c05ae2024-02-29WarningsExact identifier
application number: M017
LidoPro PatchLIDOCAINE, MENTHOL, AND METHYL SALICYLATEAdvanced Rx Pharmacy of Tennessee, LLC128d0ba9-bc9d-af16-e063-6394a90af5ef2024-02-29WarningsExact identifier
application number: M017
Leader Roll-On Cooling Pain Relief Topical AnalgesicMENTHOL, UNSPECIFIED FORMCardinal Health, 110 dba LEADERe86cba40-6b10-454d-98b3-6b547456eaad2024-02-29WarningsExact identifier
application number: M017
Maximum Strength Scalp Itch Relief Anti-itchHYDROCORTISONERite Aid55569563-fc38-4f97-8e74-9f96e31733842024-02-28WarningsExact identifier
application number: M017
Walgreens Eczema ReliefHYDROCORTISONE ACETATEWalgreen Co.4a65a1bf-aa24-4452-9ec3-a28c8bf0e47c2024-02-28WarningsExact identifier
application number: M017
meijer Cold Therapy Pain Relieving analgesicMENTHOL, UNSPECIFIED FORMMeijer Distribution, Incfb163112-d84d-418d-a410-3214c0ee4b5a2024-02-28WarningsExact identifier
application number: M017
SunBurnt PLUSLIDOCAINE HYDROCHLORIDEQuest Products, LLC.12128c75-015d-8a72-e063-6394a90ae00a2024-02-23WarningsExact identifier
application number: M017
Kroger Analgesic AnalgesicLIDOCAINE HYDROCHLORIDETHE KROGER COe6c5ead3-87d0-48ed-a4dc-86cf89ebb2852024-02-22WarningsExact identifier
application number: M017
Rugby Pain Relieving AnalgesicMENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATEBryant Ranch Prepackfcf48536-224e-4a3d-9124-7700318239722024-02-22WarningsExact identifier
application number: M017
meijer ROLL-ON Cold Therapy Pain Relieving Topical analgesicMENTHOL, UNSPECIFIED FORMMeijer Distribution, Inc8bc3956b-b82d-4ed3-8bc3-db0078466bbc2024-02-22WarningsExact identifier
application number: M017
Promescent Delay WipesBENZOCAINEAbsorptionf0a5b6be-acc5-473c-9054-b9534e769db12024-02-20WarningsExact identifier
application number: M017
Ralli Rapid Pain ReliefMENTHOLTroy Manufacturing, Inc.721658dc-3b1d-43ff-9032-e96851633cf92024-02-19WarningsExact 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