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 295 of 352 · 7,030 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JUNGSAEMMOOL Essential Skin Nuder Longwear Cushion Medium DeepTITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE, OCTISALATEJungsaemmool Beauty Co., Ltd.f31842f7-3474-4462-87e2-c4ebde97a5832024-08-04WarningsExact identifier
application number: M020
JUNGSAEMMOOL Essential Skin Nuder Longwear Cushion MediumTITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE, OCTISALATEJungsaemmool Beauty Co., Ltd.ccfafefc-fff4-41ff-baf4-3f430c690be72024-08-04WarningsExact identifier
application number: M020
Alba Botanica Sheer Mineral SPF50ZINC OXIDEThe Hain Celestial Group, Inc.f4a02196-288e-1958-e053-2a95a90a53052024-07-31WarningsExact identifier
application number: M020
Very Emollient Body Daily Shade SPF15AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEThe Hain Celestial Group8eeb25a8-337d-c71b-e053-2995a90a091a2024-07-31WarningsExact identifier
application number: M020
Clarity Rx Pucker Power lip plumper SPF 30HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONETopiderm, Inc.92504982-fe0e-404d-b7cf-f6b340b898022024-07-31WarningsExact identifier
application number: M020
Essential Sheer SPF 50ZINC OXIDE TITANIUM DIOXIDETopiderm, Inc.2132dc18-85ee-4449-86d2-d9f698f286c62024-07-31WarningsExact identifier
application number: M020
Proceuticals Private Label by TiZO tinted foaming mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, Ltd1e78109f-4d2e-2705-e063-6294a90a5ad32024-07-30WarningsExact identifier
application number: M020
Replenix Sheer SPF 50ZINC OXIDE TITANIUM DIOXIDETopiderm, Inc.37d1f454-3bc9-4ce5-863c-0d4f6fa18fb42024-07-29WarningsExact identifier
application number: M020
Dr Pawpaw MultiPurpose Lip Balm with natural PawPaw and SPF 30AVOBENZONE, OCTINOXATE, OCTOCRYLENE, HOMOSALATE, OCTISALATEDr Pawpaw Limitedf2628e3e-9eb0-49cb-91a6-d15c48cb8a192024-07-25WarningsExact identifier
application number: M020
Thinksport Daily Face SPF 50ZINC OXIDEthinkOperations,LLCb2422785-bd35-4248-a68f-fb4b1492a4cd2024-07-24WarningsExact identifier
application number: M020
Thinkbaby Clear Zinc SPF 30ZINC OXIDEthinkOperations,LLC7cd9c971-5556-42dc-af7b-3a88221b8c942024-07-24WarningsExact identifier
application number: M020
ISNTREE ONION NEWPAIR SUNSCREENAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEISNTREE Inc.0f072099-d57d-4dc4-e063-6394a90ab4382024-07-23WarningsExact identifier
application number: M020
ISNTREE ONION NEWPAIR SUNSCREENAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEISNTREE Inc.14b11b42-d1fe-572f-e063-6394a90a9eec2024-07-23WarningsExact identifier
application number: M020
Proceuticals Private Label by TiZO tinted mineral sunscreen 20% zinc oxideZINC OXIDEFallien Cosmeceuticals, Ltd1dda8259-4121-3c76-e063-6394a90af1892024-07-22WarningsExact identifier
application number: M020
Eco Lips PlantPod Sunscreen Lip Balm Sport SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEEco Lips. Inc.e64c8644-7af4-7b7f-e053-2995a90af7112024-07-22WarningsExact identifier
application number: M020
Thinksport SPF 30ZINC OXIDEthinkOperations,LLC2cecda56-4860-4d35-abc2-2bb9bdf35eae2024-07-19WarningsExact identifier
application number: M020
CVS Health SPORT SPF 30AVOBENZONE HOMOSALATE OCTOCRYLENECVS PHARMACYf0e8c724-b377-5dc0-e053-2995a90a0d542024-07-18WarningsExact identifier
application number: M020
EQUATE Sunscreen SPORT Broad Spectrum SPF 30AVOBENZONE HOMOSALATE OCTOCRYLENEWAL-MART STORES INC4d819fd3-de12-4394-82f4-a48faf0b70922024-07-18WarningsExact identifier
application number: M020
Big Lots Soundbody SPF 30 Ultra Sport SunscreenAVOBENZONE HOMOSALATE OCTOCRYLENEBIG LOTS STORES, INC.f0e82a9f-17ac-b1c5-e053-2995a90ae07a2024-07-18WarningsExact identifier
application number: M020
Equaline SPORT Sunscreen SPF 30AVOBENZONE HOMOSALATE OCTOCRYLENEUnited Natural Foods, Inc. dba UNFIf0e8dfd4-a77c-6384-e053-2a95a90a1e4a2024-07-18WarningsExact 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