FDA.reportPublic FDA data

Aruba Aloe broad spectrum SPF 15 Lip sunscreen and Moisturizer

Product NDC
53675-208
11-digit product format
536750208
Labeler code
53675
Product ID
53675-208_0eae7a1b-f5ac-eb4a-e063-6394a90af2c5
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE
Dosage form
STICK
Route
TOPICAL
Labeler
Aruba Aloe Balm NV
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-12-14
Substance
AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OCTISALATE
Active strength
30; 73.4; 50; 50 mg/g; mg/g; mg/g; mg/g
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 broad spectrum SPF 15 Lip sunscreen and Moisturizer
Listing expiration
2027-12-31

Active Ingredients#

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

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
9e3ed6dc-14ba-4bb2-a633-1a1fe92099ceAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53675-208-00Aruba Aloe broad spectrum SPF 15 Lip sunscreen and Moisturizer4.8 g in 1 PACKAGESTICK4.81

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53675-208ARUBA ALOE BROAD SPECTRUM SPF 15 LIP SUNSCREEN AND MOISTURIZER (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) STICK [ARUBA ALOE BALM NV]1Current NDC, 1 package rows20240112_9e3ed6dc-14ba-4bb2-a633-1a1fe92099ce.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 292 of 352 · 7,030 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mario Badescu SPF 17AVOBENZONE, OCTINOXATE, OCTOCRYLENEBentley Laboratories LLC0fd51f8d-ee67-48fd-ab98-1fedb03394622024-09-10WarningsExact identifier
application number: M020
Mario Badescu Collagen SPF 15AVOBENZONE, OCTINOXATE, OXYBENZONEBentley Laboratories LLC0246b11b-f1ba-4f47-91ab-52a6554b94672024-09-10WarningsExact identifier
application number: M020
Mario Badescu The Moisture Magnet SPF 15AVOBENZONE, OCTINOXATE, OXYBENZONEBentley Laboratories LLCf6d653f5-52a0-42ad-8308-b8d6f57050cc2024-09-10WarningsExact identifier
application number: M020
MARIO BADESCU SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBentley Laboratories LLCfe485d4c-0ded-4061-ac34-77b72d5350902024-09-10WarningsExact identifier
application number: M020
MARIO BADESCU ALOE SPFAVOBENZONE, OCTINOXATE, OXYBENZONEBentley Laboratories LLC189a7421-8598-44fc-9506-13c6dff8989c2024-09-10WarningsExact identifier
application number: M020
Aveeno Baby Continuous Protection Sensitive Skin Sunscreen Broad Spectrum SPF 50ZINC OXIDEKenvue Brands LLC17a7492b-5243-48c4-b808-5e9899db75302024-09-08WarningsExact identifier
application number: M020
Proceuticals Private Label by TiZO tinted mineral sunscreen stickTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, Ltd2179a2ff-9425-5b2c-e063-6294a90a45b62024-09-06WarningsExact identifier
application number: M020
EltaMD UV Physical Rosy Tint SPF40TITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc6bc4d2d4-ef62-4ec0-b514-17257603bac22024-09-05WarningsExact identifier
application number: M020
SPF15 lip balm 01OCTOCRYLENE, OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.20e122e2-09ad-63ad-e063-6294a90a83fc2024-08-30WarningsExact identifier
application number: M020
Proceuticals Private Label by TiZO non-tinted mineral sunscreen stickTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, Ltd20e86260-d641-c9ac-e063-6394a90ac07d2024-08-30WarningsExact identifier
application number: M020
OS-01 Body SPF 30ZINC OXIDEONESKIN, INC20eb4d43-cf4d-dde3-e063-6394a90a6cb82024-08-30WarningsExact identifier
application number: M020
Freaks of Nature Peak Performance SPF50FREAKS OF NATURE PEAK PERFORMANCE SPF50Milbar Laboratories20b18cea-95e9-3527-e063-6294a90a4db42024-08-30WarningsExact identifier
application number: M020
JACKET SPF-50 Broad Spectrum SunscreenZINC OXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBALSHI MD DERMACEUTICALSfcc45edd-098c-4f27-9712-0db36cfa0fdc2024-08-29WarningsExact identifier
application number: M020
LA MER THE BROAD SPECTRUM SPF 50 UV PROTECTING FLUIDAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEMAX HUBER RESEARCH LAB INCe06bb578-475c-4169-ac09-cefb6a37d3922024-08-29WarningsExact identifier
application number: M020
dr. brandt SUN SHIELD SPF 50ZINC OXIDEDr. Brandt6f8af59b-d423-4250-8ddc-061fea886e3e2024-08-28WarningsExact identifier
application number: M020
dAlba Vegan Tone-Up SunscreenHOMOSALATE, ETHYLHEXYL METHOXYCINNAMATE,TITANIUM DIOXIDEADMTMAX LLC20adebef-2841-a5c2-e063-6394a90ab0632024-08-27WarningsExact identifier
application number: M020
doTERRA sun Lip Balm Mineral SunscreenMINERAL SUNSCREENdoTERRA International, LLC20afcd34-efa6-30a7-e063-6394a90ab5172024-08-27WarningsExact identifier
application number: M020
SPF15AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEZhejiang Ayan Biotech Co.,Ltd.2bb9798f-36a0-4d03-a316-8b746a9283d82024-08-26WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF30TITANIUM DIOXIDE AND ZINC OXIDEDermio Dermatology LLC204973ce-dba4-8235-e063-6394a90a015c2024-08-22WarningsExact identifier
application number: M020
SUNSCREEN 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.202e99ef-330e-ad94-e063-6294a90a2d2a2024-08-21WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53675-208-00536750208004.8 g in 1 PACKAGE (53675-208-00) 4.8 g2023-12-14NoNoCurrent