FDA.reportPublic FDA data

Aruba Aloe Hydrating Aloe Rich Sunscreen SPF 50

Product NDC
53675-210
Requested package NDC
53675-210-01
11-digit product format
536750210
Labeler code
53675
Product ID
53675-210_297be25a-30e0-e918-e063-6294a90a384a
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
2024-04-11
Substance
AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OCTISALATE
Active strength
30; 73.4; 100; 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 50
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/mL
HOMOSALATE73.4 mg/mL
OCTOCRYLENE100 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
acda1640-0d35-43dc-8734-d47b00cc85edAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53675-210-01Aruba Aloe Hydrating Aloe Rich Sunscreen SPF 5059 mL in 1 TUBECREAM591
53675-210-02Aruba Aloe Hydrating Aloe Rich Sunscreen SPF 50177 mL in 1 TUBECREAM1771

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53675-210ARUBA ALOE HYDRATING ALOE RICH SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) CREAM [ARUBA ALOE BALM NV]1Current NDC, 2 package rows20241219_acda1640-0d35-43dc-8734-d47b00cc85ed.zip

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 266 of 352 · 7,030 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PLAY Antioxidant Body Mist SPF 50 With Vitamin CAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLC9c5c0608-3f42-6640-e053-2a95a90a50862024-12-04WarningsExact identifier
application number: M020
LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 PERLA 100TITANIUM DIOXIDE, ZINC OXIDEBEL STAR S Ae4bb5a32-c5dc-86d5-e053-2a95a90a49382024-12-04WarningsExact identifier
application number: M020
Burts Bees Firming Day SPF30ZINC OXIDEBurts Beesf028ffea-184b-46db-9e48-dab4a535bf002024-12-03WarningsExact identifier
application number: M020
Burts Bees Calming Day SPF30ZINC OXIDEBurts Beese406e6ba-fa6d-452d-bc29-404e2f8fcf3e2024-12-03WarningsExact identifier
application number: M020
Alumier MD Moisture Matte Broad Spectrum SPF 40 Sunscreen AmberZINC OXIDE, TITANIUM DIOXIDEAlumier Labsba864a08-e66d-d286-e053-2995a90a18542024-12-03WarningsExact identifier
application number: M020
Alumier MD Sheer HydrationTITANIUM DIOXIDE, ZINC OXIDEAlumier Labs2874e531-d647-339c-e063-6394a90ac86f2024-12-03WarningsExact identifier
application number: M020
REEF SAFE Unscented SPF Mineral Sunscreen 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.286965aa-0961-0141-e063-6394a90aa3f02024-12-03WarningsExact identifier
application number: M020
Alumier MD Sheer Hydration Tinted Moisturizing SunscreenTITANIUM DIOXIDE, ZINC OXIDEAlumier Labsa951ebe7-7786-38ef-e053-2995a90a70e32024-12-03WarningsExact identifier
application number: M020
MUSTELA MINERAL SUNSCREEN BROAD SPECTRUM SPF 50ZINC OXIDE, TITANIUM DIOXIDEExpanscience Laboratories d/b/a Mustelabeec926c-35a5-1901-e053-2a95a90ad0432024-12-02WarningsExact identifier
application number: M020
MUSTELA MINERAL SUNSCREEN SPF 50ZINC OXIDEExpanscience Laboratories d/b/a Mustelab850f68e-4f52-6902-e053-2995a90aaa912024-12-02WarningsExact identifier
application number: M020
Hero Force Shield Superbeam Sunscreen SPF 30 ApricotZINC OXIDEChurch & Dwight Co., Inc.133dc4db-6598-4400-8aa4-022f66eb28fc2024-12-02WarningsExact identifier
application number: M020
AHAVA MultiVitamin Day SPF30AVOBENZONE, ENSULIZOLE, OCTISALATE, AND OCTOCRYLENEAHAVA - Dead Sea Laboratories Ltdd9b8e9ae-ed05-4e9c-8d01-8fac183053a42024-12-02WarningsExact identifier
application number: M020
ATTITUDE Sunly Mineral Sunscreen Face Stick Unscented SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0d8551c6-2efe-11a8-e063-6294a90aed012024-12-01WarningsExact identifier
application number: M020
ATTITUDE Oatmeal Sensitive Natural Mineral Sunscreen Face Stick Unscented SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0d958343-31e3-0b7a-e063-6294a90a424a2024-12-01WarningsExact identifier
application number: M020
Attitude Kids mineral sunscreen unscented SPF 30ZINC OXIDE9055-7588 Qubec Inc. DBA Attitudec2461e22-1518-4f9e-ad8c-951784ef8b5f2024-12-01WarningsExact identifier
application number: M020
BIO SPECTRA ATTITUDEZINC OXIDE9055-7588 Quebec Inc. DBA Attitude954713fe-c84c-41b4-913d-3507ed91e55d2024-12-01WarningsExact identifier
application number: M020
CAUDALIE Daily Mineral Sunscreen Broad Spectrum SPF 50ZINC OXIDECaudalie USA, Inc.150e3bf3-7b05-e611-e063-6294a90a09322024-11-29WarningsExact identifier
application number: M020
CLEARING DEFENSE SPF30OCTOCRYLENE, HOMOSALATE, OCTISALATE, AND AVOBENZONEDermalogica, LLC.2cb559d3-dd79-4951-ad38-190fd4dd7c402024-11-27WarningsExact identifier
application number: M020
Neutrogena Collagen Bank SPF Moisturizer Sunscreen Broad Spectrum SPF 30 and Neutrogena Collagen Bank MoisturizerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLC1ccde0bc-08aa-8a25-e063-6394a90a27622024-11-25WarningsExact identifier
application number: M020
Girlyish Skincare Mineral Sunscreen SPF 30ZINC OXIDERise Skincare LLC137ba0be-91ce-4bd0-9713-57b1693597502024-11-25WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53675-210-015367502100159 mL in 1 TUBE (53675-210-01) 59 ml2024-04-11NoNoCurrent