FDA.reportPublic FDA data

Aloe Up SPF 50 Mineral

Product NDC
61477-232
11-digit product format
614770232
Labeler code
61477
Product ID
61477-232_37d95f06-6460-88da-e063-6394a90a6dcd
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 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
35b9dcfa-05f3-3d7b-e063-6394a90a18f1Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61477-232-01Aloe Up SPF 50 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 51 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Certain Dri Clinical Strength Prescription Protection RollonCERTAIN DRI CLINICAL STRENGTH PRESCRIPTION PROTECTION ROLLONClarion Brands LLC46a1f92e-4411-3989-e063-6394a90a70382025-12-23WarningsExact identifier
application number: M017
PREMIERES PAINMENTHOLPremiere Enterprises128bd1e7-e961-416c-933b-fbd146e3d3862025-12-23WarningsExact identifier
application number: M017
PREMIERES PAINMENTHOLPremiere Enterprises35ff19df-4cc4-4fce-bd30-d87d835e0e262025-12-23WarningsExact identifier
application number: M017
Premieres PainMENTHOLPremiere Enterprises1f081913-6106-4d06-a37a-631f710dbacb2025-12-23WarningsExact identifier
application number: M017
ABSORBINE jr.LIDOCAINE HCL, PHENOLClarion Brands, LLCe1de73bb-917c-48d1-9a78-00c76edddb982025-12-23WarningsExact identifier
application number: M017
ABSORBINE jr. PLUS KneeCAMPHOR, MENTHOLClarion Brands, LLC3ad8718d-ebf1-474f-8a91-48c78ab3b5c12025-12-23WarningsExact identifier
application number: M017
Absorbine Jr. PlusMENTHOLClarion Brands, LLCfd5d77fc-dc73-2aec-2c7f-0fca5d7d3a752025-12-23WarningsExact identifier
application number: M017
ABSORBINE JR PLUS ULTRA STRENGTH PAINMENTHOLClarion Brands, LLCcf329707-d90a-29dd-f2c2-acfd5af614f32025-12-23WarningsExact identifier
application number: M017
Absorbine Jr Pro CreamLIDOCAINE HCL, PHENOLClarion Brands, LLC17b3f1e6-5554-4f3e-b133-76ae8ffea9192025-12-23WarningsExact identifier
application number: M017
Absorbine Jr Pro No Mess Roll-on PlusLIDOCAINE HCL, PHENOLClarion Brands, LLCa7172f17-1525-4738-b72c-92479c730af22025-12-23WarningsExact identifier
application number: M017
ABSORBINE JRMENTHOLClarion Brands, LLCd656e7f6-ca26-1873-6c11-08aa82091bb02025-12-23WarningsExact identifier
application number: M017
Relief RecoveryMETHYL SALICYLATEMayway Corporation27afd45e-2dc5-d099-e063-6394a90ad2b72025-12-23WarningsExact identifier
application number: M017
MobilityMETHYL SALICYLATEMayway Corporation27af9d17-9c15-5e2a-e063-6394a90aeda52025-12-23WarningsExact identifier
application number: M017
medlot pain relief gel patchLIDOCAINELotfancy, Inc.3ce4af20-b227-5b98-e063-6394a90ab9922025-12-23WarningsExact identifier
application number: M017
Nizoral Scalp Itch ReliefHYDROCORTISONEKramer Laboratoriesdba59238-6beb-447e-8c4c-e4bc00fd2c202025-12-23WarningsExact identifier
application number: M017
Salonpas LIDOCAINE Pain RelievingLIDOCAINEHisamitsu America, Inc.63911880-8194-4c7d-a72f-cab94761b2d72025-12-23WarningsExact identifier
application number: M017
The Body Builders CreamMENTHOLSmart Cookie Solutionsf803325e-eb86-4b9e-a401-0a91bdcd63892025-12-22WarningsExact identifier
application number: M017
PROINNATE Numbing CreamLIDOCAINE,MENTHOLGuangdong Aimu Biological Technology Co., Ltd46895ddb-0b9f-675e-e063-6394a90adf232025-12-22WarningsExact identifier
application number: M017
Caring Mills Vaginal Anti-Itch CreamBENZOCAINE, RESORCINOLVeridian Healthcaref2362658-aea2-438e-a66c-738022e6e0472025-12-22WarningsExact identifier
application number: M017
HealthWise Pain Relieving Menthol GelMENTHOL 2%Veridian Healthcare396d0fd4-67be-4de1-8f0c-42c83dfe91202025-12-22WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
61477-232-0161477023201128 g in 1 CAN (61477-232-01) 128 g2025-05-22NoNoCurrent