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 331 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LA MER THE RADIANT SKINTINT BROAD SPECTRUM SPF 30OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDEMAX HUBER RESEARCH LAB INCecc942c7-5495-43b1-9ffa-d38be78911522023-10-30WarningsExact identifier
application number: M020
Babo Botanicals Sheer Zinc Mineral Sunscreen SPF30ZINC OXIDEBabo Botanicals, Inc.08f0f32e-4b19-7a62-e063-6394a90af1b12023-10-30WarningsExact identifier
application number: M020
BANANA BOAT PROTECTION PLUS VITAMINS SUNSCREEN UVA/UVB BROAD SPECTRUM SPF 50AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCe5e5777c-2f67-14ed-e053-2a95a90a58a52023-10-30WarningsExact identifier
application number: M020
CoreTex Sun X SPF 30 NewAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECoreTex Products Inc08fb4748-d22d-35af-e063-6394a90a08272023-10-30WarningsExact identifier
application number: M020
LIVE TINTED Hueguard 3-in-1 Mineral Sunscreen Moisturizer Primer Broad Spectrum SPF 30ZINC OXIDELive Tinted, Inc.d177b085-2bbd-49c1-b02b-a7b8d8ee04682023-10-28WarningsExact identifier
application number: M020
Live Tinted Hueguard 3-in1 Mineral Sunscreen Moisturizer Primer Broad Spectrum SPF 30ZINC OXIDELive Tinted, Inc.cfceaf45-bab5-6858-e053-2a95a90a6be12023-10-28WarningsExact identifier
application number: M020
LIVE TINTED Hueguard Invisible Sunscreen Stick Broad Spectrum SPF 50 Water Resistant 80 MinsHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONELive Tinted, Inc.8e4d7c84-5acb-4857-860d-bf6837e4901e2023-10-28WarningsExact identifier
application number: M020
LIVE TINTED Hueguard 3-in-1 Mineral Sunscreen Moisturizer Primer Broad Spectrum SPF 30ZINC OXIDELive Tinted, Inc.7bceeb0e-b557-438c-88ac-0148f6eb1b4d2023-10-28WarningsExact identifier
application number: M020
Green Defense daily mineral sunscreen Broad Spectrum SPF 30ZINC OXIDEFarmacy Beauty LLCd1ae2696-fd1b-4422-a8e0-5209aeeb97eb2023-10-28WarningsExact identifier
application number: M020
LIVE TINTED Glow-up Hyperpigmentation EssentialsZINC OXIDELive Tinted, Inc.ef06c1eb-6ce3-4b1b-8a7d-3e29ae1728442023-10-28WarningsExact identifier
application number: M020
SPF Elio Drops 30 SheerZINC OXIDEAllure Labs Inc08c9fc56-7d4f-ebc5-e063-6294a90a53172023-10-28WarningsExact identifier
application number: M020
SPF Elio Drops 30 GlowZINC OXIDEAllure Labs Inc08cbf8d6-8c27-1567-e063-6394a90a932e2023-10-28WarningsExact identifier
application number: M020
RESILIENCE MULTI-EFFECT TRI-PEPTIDE FACE AND NECK CREME BROAD SPECTRUM SPF 15 dry skinAVOBENZONE, OCTISALATE, AND OCTOCRYLENEESTEE LAUDER INCd1ca8372-28a0-41e1-b92a-913fc09f71562023-10-27WarningsExact identifier
application number: M020
Vivier Sheer SPF 30 MineralTITANIUM DIOXIDE, ZINC OXIDEVivier Pharma, Inc.1be5ee36-3566-495c-aae2-4d0d7fc210ed2023-10-27WarningsExact identifier
application number: M020
Vivier Sheer SPF 45ZINC OXIDE, OCTOCRYLENE, OCTINOXATE, OCTISALATEVivier Pharma, Inc.c057138a-1111-4e7c-b94d-2ccd6bc3963c2023-10-27WarningsExact identifier
application number: M020
360 by QUR Spanish lime lip balmOCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEQur, Incbedb3347-7498-3d7a-e053-2995a90a4b122023-10-26WarningsExact identifier
application number: M020
360 by QUR Vanilla lace lip balmOCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEQur, Incbedb4c53-adaa-3a8a-e053-2a95a90ae93a2023-10-26WarningsExact identifier
application number: M020
360 by QUR Watercress mint lip balmOCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEQur, Incbedb7413-c074-a2d7-e053-2a95a90ac5cb2023-10-26WarningsExact identifier
application number: M020
PRIDEFUL SPF 15 LIP BALM-cherry vanillaHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEPRIDEFUL LLCc827c6b4-c6d7-4585-b615-419db9520e7c2023-10-26WarningsExact identifier
application number: M020
PRIDEFUL SPF 15 LIP BALM-citrusHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEPRIDEFUL LLC2f20ee7e-3897-4263-b965-5155d89bfb5e2023-10-26WarningsExact 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