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 277 of 352 · 7,030 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ALDI LACURA KIDS SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEALDI INCe34f37d7-02a5-0b72-e053-2a95a90acf832024-10-21WarningsExact identifier
application number: M020
Aldi Lacura Ultra Light Body SPF 100AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEALDI INCf7ac082c-def8-4379-e053-6294a90a57e32024-10-21WarningsExact identifier
application number: M020
Aldi LACURA Sport Sunscreen 30 Broad Spectrum SPF 30 ContinuousAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEALDI INCf7bdc1f7-d961-4596-e053-6394a90a1d872024-10-21WarningsExact identifier
application number: M020
Aldi LACURA Ultra Light Dry-Touch 100 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEALDI INCf7b2cf4e-468c-3406-e053-6394a90a21392024-10-21WarningsExact identifier
application number: M020
Aldi LACURA Sport Sunscreen 50 Broad Spectrum SPF 50 ContinuousAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEALDI INCf7b32aa8-2e56-3725-e053-6294a90a18d22024-10-21WarningsExact identifier
application number: M020
Bliss Block Star Sheer Liquid Daily Sunscreen SPF 50 SPF-50ZINC OXIDEBliss Products Holdings LLCf262e5a7-3c57-a6d8-e053-2995a90aacbc2024-10-21WarningsExact identifier
application number: M020
Berkley Jensen Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBJWCfbd65277-7aff-de19-e053-6394a90a94962024-10-21WarningsExact identifier
application number: M020
Sun Bum SPF 15 Premium Moisturizing SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC01bfe44c-655f-404c-981e-8d5f6728a7382024-10-21WarningsExact identifier
application number: M020
Sun Bum SPF 70 Premium Moisturizing SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLCaa612570-b70a-4910-8086-6634834beb702024-10-21WarningsExact identifier
application number: M020
Premium Moisturizing Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum LLCf5bd673a-46e5-43d5-9d76-8ddc5da701462024-10-21WarningsExact identifier
application number: M020
Sun Bum Kids Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum LLC6fcec9f9-bee0-4884-8c72-be273426f9162024-10-21WarningsExact identifier
application number: M020
sunscreenSKIN BARRIER SUN SHIELD SPF 30True Botanicals, Inc.d70eea23-7715-c17b-e053-2a95a90a839f2024-10-18WarningsExact identifier
application number: M020
First Aid Only SunX30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAcme United Corporation24c22903-8911-81d9-e063-6394a90a108b2024-10-18WarningsExact identifier
application number: M020
TiZO Eye Renewal SPF 20 (Non-Tinted)ZINC OXIDEFallien Cosmeceuticals, LTD33f8760c-2953-44a6-9239-424fdb97a5b32024-10-18WarningsExact identifier
application number: M020
Fruit of the Earth Sun Town City SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFruit of the Earth, Inc.c85e5094-d442-55a9-e053-2995a90aed122024-10-18WarningsExact identifier
application number: M020
Bondi Sands SPF 60 Sunny FaceAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBONDI SANDS (USA) INC.24c78897-3136-f24b-e063-6394a90aa80a2024-10-18WarningsExact identifier
application number: M020
Fruit of the Earth Sun Town City Baby and Kids Mineral SPF 50 SunscreenTITANIUM DIOXIDE, ZINC OXIDEFruit Of The Earth, Inc.f42a0b1e-038d-4fab-e053-2995a90a53642024-10-18WarningsExact identifier
application number: M020
Cabana Beach Club with Manuka Honey and Essential Oils SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFruit of the Earth, Inc.f451c472-1d9f-1fbc-e053-2995a90a114e2024-10-18WarningsExact identifier
application number: M020
Fruit of the Earth Sun Town City Mineral SPF 30 SunscreenZINC OXIDEFruit Of The Earth, Inc.f4490608-6cce-90f3-e053-2995a90a49302024-10-18WarningsExact identifier
application number: M020
Fruit of the Earth Sun Town City Mineral SPF 70 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEFruit Of The Earth, Inc.f540b0f6-3e6c-43a7-e053-2a95a90aba742024-10-18WarningsExact 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