FDA.reportPublic FDA data

Aruba Aloe Hydrating Aloe Rich Sunscreen SPF 30

Product NDC
53675-211
Requested package NDC
53675-211-01
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 317 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Slip Tint Broad Spectrum SPF 35 Tinted MoisturizerZINC OXIDEClean Beauty For All, Incccf9daf4-0bf0-2610-e053-2a95a90a3f072023-12-12WarningsExact identifier
application number: M020
MINERAL BODY SUNSCREEN UNSCENTEDZINC OXIDESynchronicity Spa, Inc. DBA Suntegrity17cb6a73-5bfe-4227-ab9f-f6dd90bac2662023-12-12WarningsExact identifier
application number: M020
Vichy Laboratoires Capital Soleil 60 Mineral Sunscreen Broad Spectrum SPF 60 Water Resistant 80 Minutes Sheer Tint Ultra LightweightTITANIUM DIOXIDELOreal USA Products Inc4692b146-1abe-48e8-b097-ea9c556962b62023-12-11WarningsExact identifier
application number: M020
Vichy Laboratories LiftActiv Peptide-C SPF 30 Phyto Peptides Vitamin CAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc40fd5146-f4f0-4c2d-a786-d18f8ade1bef2023-12-11WarningsExact identifier
application number: M020
Vichy Laboratories LiftActiv Peptide-C SPF 30 Sunscreen Phyto Peptides Vitamin CAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENECosmetique Active Productsf5b3e52e-64f7-4e97-ba74-60de904b87712023-12-11WarningsExact identifier
application number: M020
Vichy Laboratoires Capital Soleil 60 Mineral Broad Spectrum SPF 60 Water Resistant 80 Minutes Sheer Tint Ultra Lightweight SunscreenTITANIUM DIOXIDECosmetique Active Productionacb887bc-7e46-4257-9fe3-a2cade6c4f382023-12-11WarningsExact identifier
application number: M020
Solar Defense BodyAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEHydroPeptide LLC45ec77c5-5eb3-0e51-e054-00144ff8d46c2023-12-09WarningsExact identifier
application number: M020
Erborian BB creme au Ginseng chocolate SPF 20OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&Lddcd6ea4-e7b1-88df-e053-2a95a90a99232023-12-09WarningsExact identifier
application number: M020
ERBORIAN - BB CREME AU GINSENG CARAMEL SPF20OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L43c81760-6bb6-25fe-e054-00144ff8d46c2023-12-09WarningsExact identifier
application number: M020
Erborian CC Dull Correct SPF25OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&Lcb23ba95-1e83-4523-a35c-3b70c0605dd12023-12-09WarningsExact identifier
application number: M020
Carmex Classic Lip Balm Medicated Free Wintergreen StickOCTINOXATE, OXYBENZONE, CAMPHOR (SYNTHETIC), WHITE PETROLATUMCarma Laboratories, Inc.bc0162bc-92ca-ee78-e053-2a95a90a7c9d2023-12-08WarningsExact identifier
application number: M020
Raw Elements Eco Formula SPF30 Sample PacksZINC OXIDERaw Elements LLC9e91e228-0b5e-4577-9d57-cdb9e9a705e82023-12-08WarningsExact identifier
application number: M020
Multi-Active Jour SPF 20 Broad Spectrum SunscreenAVOBENZONE,HOMOSALATE,OCTOCRYLENELaboratoires Clarins432f07e8-6f0f-4946-b1b6-4559ef1af5612023-12-08WarningsExact identifier
application number: M020
CLARINS - EXTRA-FIRMING JOUR SPF 15 - Wrinkle, Firming Day all skin types - Broad Spectrum SPF 15 SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENELaboratoires Clarinsae34fdcb-d372-435f-bf7c-075ea554b2fe2023-12-08WarningsExact identifier
application number: M020
UV ESSENTIEL COMPLETE UV PROTECTION SUNSCREEN ANTIOXIDANT ANTI-POLLUTION BROAD SPECTRUM SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENECHANEL PARFUMS BEAUTEdf2a43b4-eab9-48cd-a4b6-d00cfc9254772023-12-08WarningsExact identifier
application number: M020
SERIOUS SKINCARE SERIOUS-C3 PLASMA TM BIO TECHNOLOGY C VITAMIN C ESTER PROTECTIVE DAYTIME BROAD SPECTRUM MOISTURIZER SPF 30AVOBENZONE, OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONEFlageoli Limited4833b0b1-33b7-59d4-e054-00144ff8d46c2023-12-07WarningsExact identifier
application number: M020
Cetaphil Sheer Mineral Sunscreen SPF 30TITANIUM DIOXIDE, ZINC OXIDEGalderma Laboratories, L.P.ac2d5713-9955-477e-a10f-e8a1191b5fdd2023-12-07WarningsExact identifier
application number: M020
CLARINS BROAD SPECTRUM SPF 50 Sunscreen BodyAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE,Laboratoires Clarins7feb0679-6557-4917-a386-7ce2c14a94e22023-12-06WarningsExact identifier
application number: M020
CLARINS BROAD SPECTRUM SPF 50 Dry Touch Facial SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONELaboratoires Clarins5bddb1d6-2493-41bf-8c14-73f103c55aa72023-12-05WarningsExact identifier
application number: M020
Sea Clearly Hydrating Facial SPF 35 KinetinOCTOCRYLENE, OCTISALATE,HOMOSALAT, AVOBENZONEAllure Labs0bc829ff-34a0-03e9-e063-6294a90a10ae2023-12-05WarningsExact 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