FDA.reportPublic FDA data

Aruba Aloe Hydrating Aloe Rich Sunscreen SPF 30

Product NDC
53675-211
11-digit product format
536750211
Labeler code
53675
Product ID
53675-211_385957bb-c7e0-bf5d-e063-6394a90a1837
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
2023-03-13
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 30
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
cca65f6a-935f-48d4-a07d-831ab6027db0Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53675-211-01Aruba Aloe Hydrating Aloe Rich Sunscreen SPF 3059 mL in 1 TUBECREAM592
53675-211-02Aruba Aloe Hydrating Aloe Rich Sunscreen SPF 30177 mL in 1 TUBECREAM1772

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53675-211ARUBA ALOE HYDRATING ALOE RICH SUNSCREEN SPF 30 (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) CREAM [ARUBA ALOE BALM NV]1Current NDC, 2 package rows20250323_cca65f6a-935f-48d4-a07d-831ab6027db0.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 345 of 352 · 7,030 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
La Roche Posay Laboratoire Dermatologique Mela B3 UV Daily Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc8d1c89b2-55f4-4d49-a4c2-bb0aa220ff1d2023-10-18WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Mela B3 UV Daily Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENECosmetique Active Productiond60887aa-7586-4d4b-88af-35b4f982aacf2023-10-18WarningsExact identifier
application number: M020
JESS BEAUTY Sun Drops Protection SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEJESS BEAUTY PRODUCTS LLCd13da7be-a419-4416-96be-8421665dbd822023-10-17WarningsExact identifier
application number: M020
Broad Spectrum SPF 15 Sunscreen Vanilla Lip BalmBROAD SPECTRUM SPF 15 SUNSCREEN VANILLA LIP BALMRaining Roseefe27e7e-e805-1c47-e053-2995a90af22e2023-10-17WarningsExact identifier
application number: M020
CLINIQUE FOR MEN SUPER ENGERGIZER ANTI -FATIGUE HYDRATING Concentrate BROAD SPECTRUM SPF 25AVOBENZONE AND OCTISALATECLINIQUE LABORATORIES LLCf1109f0e-ebf5-450e-8a4e-b314a91b24832023-10-13WarningsExact identifier
application number: M020
CLINIQUE BROAD SPECTRUM SPF 50 SUNSCREEN FACE WITH SOLAR SMARTAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONECLINIQUE LABORATORIES LLC8c7c0e3f-6092-413c-90f1-b3466c8a95012023-10-13WarningsExact identifier
application number: M020
Clinique Broad Spectrum SPF 30 Oil Free Face With Solar SmartOCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, AND ZINC OXIDECLINIQUE LABORATORIES LLC3d23406b-5252-4ab0-b666-77c0132b0d002023-10-13WarningsExact identifier
application number: M020
CLINIQUE BROAD SPECTRUM SPF 50 SUNSCREEN BODY WITH SOLAR SMARTAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONECLINIQUE LABORATORIES LLC94274343-3892-4c27-9d2f-c025310e29592023-10-13WarningsExact identifier
application number: M020
REDNESS solutions MAKEUP BROAD SPECTRUM SPF 15 WITH PROBIOTIC TECHNOLOGYOCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDECLINIQUE LABORATORIES LLCe557e7f3-1fa7-4dde-977f-fe3f942496c02023-10-13WarningsExact identifier
application number: M020
PEP-STAR DAILY UV PROTECTOR BROAD SPECTRUM SPF 50TITANIUM DIOXIDE AND ZINC OXIDECLINIQUE LABORATORIES LLC68cfcbc2-a214-437e-9956-f77c90d748882023-10-13WarningsExact identifier
application number: M020
MOISTURE SURGE SHEERTINT HYDRATOR BROAD SPECTRUM SPF 25OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, AND ZINC OXIDECLINIQUE LABORATORIES LLC159410d4-4479-4442-b371-bde72aae3e1e2023-10-13WarningsExact identifier
application number: M020
CLARINS UV PLUS ANTI-POLLUTION BROAD SPECTRUM SPF 50 NON-TINTED Sunscreen Multi-ProtectionHOMOSALATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDELaboratoires Clarins0695e3a4-0e8f-419e-b128-9b02bdb8b02a2023-10-11WarningsExact identifier
application number: M020
Orange Soda SPF 15 Broad Spectrum Lip BalmORANGE SODA SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca0c362ae-b878-c630-e053-2995a90ad4c42023-10-10WarningsExact identifier
application number: M020
Skin Laundry Sun Defense Mineral SPF 30 Sunscreen Broad Spectrum SPF 30 UVA UVBZINC OXIDESkin Laundry Holdings, Inc.071038d9-8179-6953-e063-6394a90a8a842023-10-06WarningsExact identifier
application number: M020
TOM FORD SHADE AND ILLUMINATE SOFT RADIANCE FOUNDATION BROAD SPECTRUM SPF 50ENSULIZOLE, OCTINOXATE, OCTISALATE, AND ZINC OXIDETOM FORD BEAUTY DIST4bae83b7-2c98-4928-8e71-bb4f19cc48f02023-10-05WarningsExact identifier
application number: M020
BB Broad Spectrum SPF 15 LightZINC OXIDE TITANIUM DIOXIDEBurt's Bees3150ef71-2ea1-25d0-e054-00144ff88e882023-10-05WarningsExact identifier
application number: M020
BB Broad Spectrum SPF 15 MediumZINC OXIDE TITANIUM DIOXIDEBurt's Bees3346f41e-32d0-35d0-e054-00144ff88e882023-10-05WarningsExact identifier
application number: M020
CLINIQUE SMART CUSTOM REPAIR MOISTURIZER BROAD SPECTRUM SPF 15 - VERY DRY/DRYAVOBENZONE AND OCTISALATECLINIQUE LABORATORIES LLC59eeb180-1ac6-44b3-9742-dc65287896bf2023-10-05WarningsExact identifier
application number: M020
REPAIRWEAR LASER FOCUS LINE SMOOTHING BROAD SPECTRUM SPF 15 -VERY DRY TO DRY COMBINATIONOCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDECLINIQUE LABORATORIES LLC4c40047b-01d6-4221-a044-9f884519bdd52023-10-05WarningsExact identifier
application number: M020
CLINIQUE SMART CUSTOM REPAIR MOISTURIZER BROAD SPECTRUM SPF 15 - COMBINATION/OILY TO OILYAVOBENZONE AND OCTISALATECLINIQUE LABORATORIES LLC9c9a0fa4-b440-4d7f-805e-d997e120024d2023-10-05WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53675-211-015367502110159 mL in 1 TUBE (53675-211-01) 59 ml2023-03-13NoNoCurrent
53675-211-0253675021102177 mL in 1 TUBE (53675-211-02) 177 ml2023-03-13NoNoCurrent