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 299 of 352 · 7,030 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUNSCREEN 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.19a8f5d5-d3c7-4a6f-e063-6294a90a94e32024-07-02WarningsExact identifier
application number: M020
All Good Coconut SPF 20 Zinc Oxide Lip BalmZINC OXIDEElemental Herbs, Inc.fdf17ffa-681b-2809-e053-6394a90a5b6e2024-07-02WarningsExact identifier
application number: M020
Sun Shield Soft Glow Daily Face SPF30HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEKoco Life LLC1c312800-4068-399e-e063-6394a90aec022024-07-01WarningsExact identifier
application number: M020
Sun on the Run KitAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEKoco Life LLC1c351485-0998-e308-e063-6394a90a9ee62024-07-01WarningsExact identifier
application number: M020
Silk Line Silk Day Cream SPF 15OCTINOXATE, OCTOCRYLENE, OCTISALATEBiocosmetica Exel Argentina SRLb2965aba-fcde-16f6-e053-2995a90aa9d82024-06-30WarningsExact identifier
application number: M020
Sun Shield On-the-Glow Sheer Stick SPF40AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEKoco Life LLC1c237d5a-1663-e9a1-e063-6294a90a6a242024-06-30WarningsExact identifier
application number: M020
Exel Clarifying Line SPF 50OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDEExelencia importers0d6d4098-4121-477e-b404-3ab18628ed682024-06-30WarningsExact identifier
application number: M020
Silk Line Silk Day Cream SPF 15OCTINOXATE, OCTOCRYLENE, OCTISALATEExelencia Importers, Corp.b2d35086-748b-55d0-e053-2995a90a18982024-06-30WarningsExact identifier
application number: M020
Maybelline New York Dream Fresh BB Beauty Balm Skin Perfector Broad Spectrum SPF 30 SunscreenTITANIUM DIOXIDEL'Oreal USA Products Inc28c51c59-dbfb-45e5-b536-6e5d5c5560d62024-06-28WarningsExact identifier
application number: M020
Sun Shield Body Glow SPF50HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEKoco Life LLC180aa4d5-6dac-e658-e063-6394a90a32872024-06-28WarningsExact identifier
application number: M020
Rose Gold Sun Shield Body Glow SPF45AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEKoco Life LLC1bf7d147-7051-2e76-e063-6294a90a1d132024-06-28WarningsExact identifier
application number: M020
Golden Amber Sun Shield Body Glow SPF30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKoco Life LLC1bf97569-024a-9ef1-e063-6394a90a28222024-06-28WarningsExact identifier
application number: M020
Jergens Natural Glow Face Daily Moisturizer for Fair/Medium SkinAVOBENZONE, OCTISALATE, OCTOCRYLENEKao USA Inc.365a98e0-737b-12b3-e054-00144ff8d46c2024-06-28WarningsExact identifier
application number: M020
Antioxidant Face Shield Mineral SPF30ZINC OXIDEKoco Life LLC1c31a971-0402-e12a-e063-6294a90ac91d2024-06-28WarningsExact identifier
application number: M020
Sun Essentials SPF Duo KitAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEKoco Life LLC1c329b86-664e-de1f-e063-6394a90a7c232024-06-28WarningsExact identifier
application number: M020
IT COSMETICS YOUR SKIN BUT BETTER CC PLUS NUDE GLOW Color Correcting Medium Coverage Skin Tint plus Brightening Glow Serum plus Broad Spectrum SPF 40 SunscreenHOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Ince879c055-9611-46a2-bcf6-8dd0a29a31292024-06-28WarningsExact identifier
application number: M020
Lancome Paris Absolue Makeup Broad Spectrum SPF 20 Sunscreen Absolute Replenishing Makeup for Dry and Very Dry SkinOCTINOXATEL'Oreal USA Products Inc90326e7e-8fdf-4221-afc0-208774d8ba6f2024-06-28WarningsExact identifier
application number: M020
LOreal Paris Collagen Moisture Filler Ultra Light Moisturizing Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Incc21fdc5e-236a-4a8e-ad59-1d9cd75074242024-06-28WarningsExact identifier
application number: M020
Kiehls Ultra Facial Moisturizer Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc6925c546-056e-4be8-b4e9-55da0b6b62b32024-06-28WarningsExact identifier
application number: M020
LOreal Paris Age Perfect Radiant Foundation Broad Spectrum SPF 50 Sunscreen with Antioxidants plus Concentrated SerumHOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc799c547c-a17a-43ee-92fc-061b5ec8a40c2024-06-28WarningsExact 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