FDA.reportPublic FDA data

Aloe Up SPF 50 Kids Mineral

Product NDC
61477-235
11-digit product format
614770235
Labeler code
61477
Product ID
61477-235_37d9953a-9625-a26f-e063-6394a90a10e2
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide, Titanium Dioxide
Dosage form
SPRAY
Route
TOPICAL
Labeler
Aloe Care International, LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-05-22
Substance
ZINC OXIDE; TITANIUM DIOXIDE
Active strength
19.5; 4 g/100g; 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 50 Kids Mineral
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE19.5 g/100g
TITANIUM DIOXIDE4 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
15FIX9V2JPInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
35cd16b0-bd81-8f68-e063-6294a90a3d8cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61477-235-01Aloe Up SPF 50 Kids Mineral128 g in 1 CANSPRAY1283

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 80 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HealthWise Overnight Menthol PatchMENTHOLVeridian Healthcare6379f50d-2878-46ca-8acb-71c4554585e92025-08-28WarningsExact identifier
application number: M017
Anti Itch Maximum ReliefPRAMOXINE HYDROCHLORIDE AND MENTHOLNatureplex LLC75de3d5e-ecbe-4d04-a39d-792200e6ee322025-08-28WarningsExact identifier
application number: M017
NicDuic Quit Smoking Nicotine PatchesNICOTINE TRANSDERMAL PATCHESShenzhen Paxi Trading Co., Ltd.3d5718f3-c175-6b64-e063-6394a90aa6f12025-08-27WarningsExact identifier
application number: M017
ARCTIC HEATMENTHOL, METHYL SALICYLATERenu Laboratories, LLC402df5c1-b8cb-17a2-e054-00144ff8d46c2025-08-27WarningsExact identifier
application number: M017
PROHEAL HYDROCORTISONE 1% MAXIMUM STRENGTH PLUS ALOEHYDROCORTISONEClick Industries LLC328c389c-7e05-4892-a9b3-b6a753f4935a2025-08-25WarningsExact identifier
application number: M017
YehealCAMPHOR, MENTHOL, ISOPROPYL ALCOHOLShenzhen Yeheal Biotechnology Co., Ltd3cf1bc74-3060-6d63-e063-6294a90a9f5c2025-08-22WarningsExact identifier
application number: M017
Dermedial Anti-OuchMENTHOLNatures Formulae Health Products Ltd.3ce29160-3964-e435-e063-6394a90abb382025-08-21WarningsExact identifier
application number: M017
SUGARLOAF ORGANICS MENTHOL REVIVEMENTHOLRENU LABORATORIES, LLCfa2f9539-b703-a00b-e053-6394a90ae3092025-08-21WarningsExact identifier
application number: M017
Camphor 4% Plus Menthol 10%CAMPHOR 4% PLUS MENTHOL 10%PureTek Corporation3cab26e4-e377-f26a-e063-6394a90a17af2025-08-20WarningsExact identifier
application number: M017
Capsaicin 0.035% CreamCAPSAICIN 0.035% CREAMPuretekcorp3cbc73b6-8c58-8f23-e063-6394a90a71a32025-08-20WarningsExact identifier
application number: M017
Game OnMENTHOL, METHYL SALICYLATENatural Essentials, Inc.3cd20f1f-033f-f698-e063-6294a90a89eb2025-08-20WarningsExact identifier
application number: M017
ELAIMEI Numbing CreamLIDOCAINE 4%Shenzhen Shandian Jingling Technology Co., Ltd.37ac13b2-ca55-0e28-e063-6294a90a000e2025-08-19WarningsExact identifier
application number: M017
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYFSA Store Inc.3cd18f96-34f7-3f2c-e063-6294a90a3b7e2025-08-19WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONE SPRAYFSA Store Inc.3ce24b87-55ac-0bbd-e063-6294a90ab5822025-08-19WarningsExact identifier
application number: M017
Fast Freeze Pain RelievingMENTHOL, UNSPECIFIED FORMNATURAL ESSENTIALS, INC.15a26af1-ca5a-40fc-a411-6c0e8ae18fbb2025-08-18WarningsExact identifier
application number: M017
Orythia Maximum Strength Lidocaine Pain RelievingLIDOCAINEPlanet (Anhui) Pharmaceutical Co., Ltd.6d6b59f9-f614-4e3c-b07b-32b4591d39f22025-08-18WarningsExact identifier
application number: M017
Ocean Potion Suncare Ice Plus Pain Relieving SoothingLIDOCAINEGNL BRANDS INTERNATIONAL, LLC3c69654c-cba6-dfef-e063-6394a90ad4792025-08-15WarningsExact identifier
application number: M017
Earth Mama Medicated Herbal Lip BalmMENTHOLEleeo Brands LLC3c6c16bb-1f4b-b851-e063-6294a90a74042025-08-15WarningsExact identifier
application number: M017
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDECintas First Aid & Safety96f17095-31f3-4b8a-ab22-0caaefaa74762025-08-15WarningsExact identifier
application number: M017
MedPride Cold Ice Analgesic GelMENTHOLSHIELD LINE LLC860a2c86-b240-4e0e-e053-2a91aa0a333a2025-08-15WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
61477-235-0161477023501128 g in 1 CAN (61477-235-01) 128 g2025-05-22NoNoCurrent