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
2026-12-31

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 144 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Non-Tinted Foaming Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETHE AESTHETICS ACADEMY, LLC3698c076-68b1-7d28-e063-6394a90a517c2025-12-09Exact identifier
application number: M020
Non-Tinted Replenishing Daily ProtectionZINC OXIDETHE AESTHETICS ACADEMY, LLC3699159a-3561-9ff6-e063-6394a90af9fd2025-12-09Exact identifier
application number: M020
Sheer Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERhonda J Pomerantz MD PLLC325c1723-fb1d-ae3c-e063-6294a90a46092025-12-09Exact identifier
application number: M020
Sheer Mineral Sunscreen Satin Dewy FinishZINC OXIDETRU SKIN RITUALS3249d05b-0f5c-4787-e063-6294a90aa0d72025-12-09Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERhonda J Pomerantz MD PLLC325c3a18-ba8f-912d-e063-6394a90a24472025-12-09Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERhonda J Pomerantz MD PLLC325c8641-1161-b8ac-e063-6394a90ae4512025-12-09Exact identifier
application number: M020
Sheer Mineral Sunscreen Silk Matte FinishTITANIUM DIOXIDE, ZINC OXIDETRU SKIN RITUALS3248eb22-1e10-2091-e063-6394a90ad3e12025-12-09Exact identifier
application number: M020
Tinted Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDERhonda J Pomerantz MD PLLC325cce54-a885-d586-e063-6394a90a90db2025-12-09Exact identifier
application number: M020
Sheer Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDETRU SKIN RITUALS324acd75-9c38-4adc-e063-6394a90afa122025-12-09Exact identifier
application number: M020
Sheer Mineral Sunscreen Satin Dewy FinishZINC OXIDETRU SKIN RITUALS324960e6-c1e7-d2b9-e063-6294a90a92ce2025-12-09Exact identifier
application number: M020
Sol Purpose Mineral Sunscreen TintedZINC OXIDETRU SKIN RITUALS324a3475-07f0-033c-e063-6394a90a811a2025-12-09Exact identifier
application number: M020
Perfect Sunscreen SPF 50 Sheer MineralZINC OXIDEBluemercury, Inc.d8f483ff-b990-40c5-b5b8-00065051ae7e2025-12-09WarningsExact identifier
application number: M020
Foto Facial Age Delay Non-TintedTITANIUM DIOXIDE ZINC OXIDEADVANCED AESTHETIC DERMATOLOGY42674013-fa2b-42d7-e063-6294a90af9992025-12-09WarningsExact identifier
application number: M020
Hydraboost Moisturizer SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEBluemercuryeca867e6-4deb-4be2-ae3f-6850fb6223b32025-12-09WarningsExact identifier
application number: M020
Foto Facial Age Delay Matte TintedTITANIUM DIOXIDE ZINC OXIDEADVANCED AESTHETIC DERMATOLOGY42761919-8ae2-3c41-e063-6394a90abb8f2025-12-09WarningsExact identifier
application number: M020
Dew MineralZINC OXIDEADVANCED AESTHETIC DERMATOLOGY42f17245-92a9-3915-e063-6394a90a68172025-12-09WarningsExact identifier
application number: M020
Mineral Sunscreen Non-TintedTITANIUM DIOXIDE, ZINC OXIDEYUMA ACNE CLINIC, L.L.C.3c69b707-07ff-1a82-e063-6394a90a9fcd2025-12-09WarningsExact identifier
application number: M020
Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEYUMA ACNE CLINIC, L.L.C.3c69f93f-0385-365c-e063-6394a90a12fd2025-12-09WarningsExact identifier
application number: M020
Replenishing Daily Protection TintedZINC OXIDEYUMA ACNE CLINIC, L.L.C.3c6a5601-a7a2-5e20-e063-6394a90a66432025-12-09WarningsExact identifier
application number: M020
Bronzing Blendrops Broad Spectrum SPF 40HOMOSALATE, OCTISALATE, ZINC OXIDEWasatch Product Development, LLC124ca946-8412-4d6d-e063-6294a90a63382025-12-09WarningsExact 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