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 288 of 352 · 7,030 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Open Nature Zinc Oxide Sunscreen Mineral Sunscreen SPF 30ZINC OXIDESafeway, Inc.dbeff8e8-250d-8274-e053-2995a90a984e2024-10-14WarningsExact identifier
application number: M020
Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 10NHOMOSALATE, ZINC OXIDERare Beauty, LLC2460281d-d433-0216-e063-6394a90a9d482024-10-13WarningsExact identifier
application number: M020
Walgreens 50 Coconut Scented Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY2436987c-2afe-06b5-e063-6394a90aceba2024-10-11WarningsExact identifier
application number: M020
Walgreens 50 Banana Scented Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY2436bd19-2299-6e89-e063-6394a90acd992024-10-11WarningsExact identifier
application number: M020
Walgreens SPF 50 Clear Complexion Face SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANYf07238df-4970-7759-e053-2a95a90a39f92024-10-11WarningsExact identifier
application number: M020
Walgreens SPF 70 Sport ContinuousAVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENEWALGREEN COMPANYe7165b39-54f9-4af6-e053-2a95a90af6642024-10-11WarningsExact identifier
application number: M020
WALGREENS SPF 100 SHEER BODY SUNSCREEN MISTAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANYf14bb3b4-1dce-06b9-e053-2995a90a8bc82024-10-11WarningsExact identifier
application number: M020
Walgreens SPF 30 SportAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANYf12c9767-7cb7-12c8-e053-2995a90a17be2024-10-11WarningsExact identifier
application number: M020
Sulwhasoo UV Daily CreamAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE CREAMAmorepacific Corporatione00451d5-8433-c4e8-e053-2a95a90a62442024-10-11WarningsExact identifier
application number: M020
Walgreens SPF 50 Sport Continuous SunscreenAVOBENZONE, HOMOSALAT, OCTISALATE, OCTOCRYLENEWALGREEN COMPANYf13ec3da-2dc2-04f7-e053-2995a90a198d2024-10-11WarningsExact identifier
application number: M020
Walgreens SPF 30 HydratingAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANYf4155692-16a7-11e8-e053-2995a90abd342024-10-11WarningsExact identifier
application number: M020
Walgreens Daily Facial Moisturizer with Broad Spectrum SPF 30 SunscreenAVOBENZONE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANYf906792b-083e-13e2-e053-6294a90ab4cf2024-10-11WarningsExact identifier
application number: M020
Walgreens Daytime Facial Moisturizer with Broad Spectrum SPF 30 SunscreenHOMOSALATE, OCTOCRYLENE, ZINC OXIDEWALGREEN COMPANYf9c81d88-8e28-fa53-e053-6394a90ac5c42024-10-11WarningsExact identifier
application number: M020
WALGREENS 100 SHEER BROAD SPECTRUM SPF 100AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANYfa18067a-310b-bdc3-e053-6394a90aee792024-10-11WarningsExact identifier
application number: M020
Walgreens 50 Mineral Zinc Oxide SunscreenZINC OXIDEWALGREEN COMPANY24223fbf-8ce9-ec5e-e063-6294a90a29da2024-10-10WarningsExact identifier
application number: M020
Walgreens 50 Mineral Zinc Oxide SunscreenZINC OXIDEWALGREEN COMPANY2422b327-ea83-f4c3-e063-6394a90a5c6e2024-10-10WarningsExact identifier
application number: M020
Walgreens 50 Watermelon Scented Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY24256e54-ae34-91b2-e063-6394a90a33c02024-10-10WarningsExact identifier
application number: M020
Walgreens 50 Premium Face Moisturizing SunscreenAVOBENZONE. HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY24265a48-fd07-c78a-e063-6394a90ab67e2024-10-10WarningsExact identifier
application number: M020
Walgreens Broad Spectrum SPF 50 Body Oil SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY2410df0a-db52-0769-e063-6394a90a52f32024-10-09WarningsExact identifier
application number: M020
Walgreens Broad Spectrum SPF 40 Radiant Facial SunscreenAVOBENZONE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY24114416-33b9-c6ba-e063-6394a90a6f3b2024-10-09WarningsExact 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