FDA.reportPublic FDA data

Aruba Aloe Hydrating Aloe Rich Sunscreen SPF 15

Product NDC
53675-214
11-digit product format
536750214
Labeler code
53675
Product ID
53675-214_3c3fb566-c899-287f-e063-6394a90ace96
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE
Dosage form
CREAM
Route
TOPICAL
Labeler
Aruba Aloe Balm NV
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-05-31
Substance
AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OCTISALATE
Active strength
30; 73.4; 50; 50 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
Aruba Aloe Hydrating Aloe Rich Sunscreen SPF 15
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/mL
HOMOSALATE73.4 mg/mL
OCTOCRYLENE50 mg/mL
OCTISALATE50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup
5A68WGF6WMInternal UNII lookup
4X49Y0596WInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6a398dad-2fb9-4cdb-86c5-2a392b88f29bAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53675-214-00Aruba Aloe Hydrating Aloe Rich Sunscreen SPF 15177 mL in 1 TUBECREAM1771

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 291 of 352 · 7,030 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Note BB 100 PorcelainOCTINOXATEALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETI4753bef0-a7f3-4629-bf23-04a145f3673c2024-09-16WarningsExact identifier
application number: M020
COOLA Dew Good Illuminating Body Melt SPF 40AVOBENZONE, OCTISALATE, OCTOCRYLENECOOLA LLC43d293f6-e13c-4ee9-89df-2a3ef0034e312024-09-16WarningsExact identifier
application number: M020
Proceuticals Private Label by TiZO non-tinted replenishing daily protectionZINC OXIDEFallien Cosmeceuticals, Ltd2203ea22-d12a-99fe-e063-6394a90aca9f2024-09-13WarningsExact identifier
application number: M020
OS-01 Face SPF BS SPF30 TintedZINC OXIDEAllure Labs22042031-ac8e-1ab2-e063-6394a90a6ed42024-09-13WarningsExact identifier
application number: M020
OS-01 Face SPF BS SPF30 TintedZINC OXIDEONESKIN INC.2204e776-b1a1-be15-e063-6294a90af5de2024-09-13WarningsExact identifier
application number: M020
OS-01 Face SPF BS SPF30 UntintedZINC OXIDEAllure Labs2205345b-5e92-37eb-e063-6294a90a6b6c2024-09-13WarningsExact identifier
application number: M020
OS-01 Face SPF BS SPF30 UntintedZINC OXIDEONESKIN INC.2205ec0e-ac3f-299f-e063-6294a90a21742024-09-13WarningsExact identifier
application number: M020
H-E-B SOLUTIONS SUNSCREEN COCONUT SPF 50 CONTINUOUSAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf4130277-ea9b-6b25-e053-2a95a90a59be2024-09-13WarningsExact identifier
application number: M020
HEB SPF 50 Tattoo Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.Bf6df491d-1fa9-a4c8-e053-6394a90a38662024-09-13WarningsExact identifier
application number: M020
Note Mattifying Extreme Wear FoundationOCTINOXATEALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETI00c7d267-4ce5-4d68-853a-05f7baeb1b052024-09-12WarningsExact identifier
application number: M020
Note Mattifying Extreme Wear Foundation 02 Natural BeigeOCTINOXATEALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETI7a4f9b2f-2187-4ba2-afdf-2e904ad53a922024-09-12WarningsExact identifier
application number: M020
Note Mattifying Extreme Wear Foundation 04 SandOCTINOXATEALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETIf98d560c-6a8c-4e76-8f76-9482979c40962024-09-12WarningsExact identifier
application number: M020
Note Mattifying Extreme Wear Foundation 07 ApricotOCTINOXATEALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETI5f97045b-439d-432f-bda4-8d3fcbcc9ad12024-09-12WarningsExact identifier
application number: M020
Note Mattifying Extreme Wear Foundation, 100 Cashmere BeigeOCTINOXATEALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETIcf375436-dc4f-4245-bc77-5ceb2cf6e7b42024-09-12WarningsExact identifier
application number: M020
Note Mattifying Extreme Wear Foundation 108 TerraOCTINOXATEALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETI9f3c34d3-a741-4107-ba24-372ff4fafe872024-09-12WarningsExact identifier
application number: M020
Note Mattifying Extreme Wear Foundation 125 Ivory BeigeOCTINOXATEALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETId75fbb71-d3cf-41c8-bb08-c4ac74c479422024-09-12WarningsExact identifier
application number: M020
Note Mattifying Extreme Wear Foundation 113 Honey BronzeOCTINOXATEALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETI6d03df27-687e-4c64-9836-cbdb8e9a08792024-09-12WarningsExact identifier
application number: M020
Note Mattifying Extreme Wear Foundation 115 EbonyOCTINOXATEALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETIf1959758-7611-44ac-8bdc-ee562d8a07fe2024-09-12WarningsExact identifier
application number: M020
Note Sunglow FoundationOCTINOXATEALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETId790ae8a-901b-4962-9684-718b54b77dc82024-09-12WarningsExact identifier
application number: M020
YOUR Day Cream Sunscreen Broad Spectrum SPF 30OCTISALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENESkin Ai, LLC21cbd5ac-5307-939b-e063-6294a90ac7912024-09-10WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53675-214-0053675021400177 mL in 1 TUBE (53675-214-00) 177 ml2025-05-31NoNoCurrent