FDA.reportPublic FDA data

Aruba Aloe Sport Line Lip Balm Broad Spectrum SPF 30

Product NDC
53675-187
11-digit product format
536750187
Labeler code
53675
Product ID
53675-187_0986480e-77d7-0bbe-e063-6294a90a1908
Type
HUMAN OTC DRUG
Nonproprietary name
TITANIUM DIOXIDE, ZINC OXIDE
Dosage form
STICK
Route
TOPICAL
Labeler
Aruba Aloe Balm NV
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-05-15
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
50; 80 mg/g; mg/g
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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 Sport Line Lip Balm Broad Spectrum SPF 30
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE50 mg/g
ZINC OXIDE80 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
80461b6d-b1b7-4220-894d-8bd425909474Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53675-187-00Aruba Aloe Sport Line Lip Balm Broad Spectrum SPF 304.8 g in 1 TUBESTICK4.82

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53675-187ARUBA ALOE SPORT LINE LIP BALM BROAD SPECTRUM SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) STICK [ARUBA ALOE BALM NV]2Current NDC, Legacy NDC, 1 package rows20231108_80461b6d-b1b7-4220-894d-8bd425909474.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 269 of 352 · 7,030 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Melan Mineral Antioxidant Body Mist Mineral Sunscreen SPF 30ZINC OXIDEMELAN INC.210823a0-94f9-4833-b279-fc26b90611952024-11-14WarningsExact identifier
application number: M020
Luminous Sunscreen SPF 50ZINC OXIDE, TITANIUM DIOXIDECLINICAL SKIN LLC26e2b82c-8d7a-7261-e063-6394a90a7c0d2024-11-14WarningsExact identifier
application number: M020
CoTZ Flawless ComplexionZINC OXIDEFallien Cosmeceuticals, LTD0973223b-e75f-4eb8-bcf1-7931b30b7b512024-11-14WarningsExact identifier
application number: M020
TiZO Photoceutical Environmental Skin ProtectantDIMETHICONEFallien Cosmeceuticals, LTD84a3299d-9b98-492e-a83f-ebd72ec58f8d2024-11-14WarningsExact identifier
application number: M020
TiZO Photoceutical AM Replenish Non-TintedZINC OXIDEFallien Cosmeceuticals, LTDc52a1e04-f3ca-47a1-a26e-d6f5e77b47d62024-11-14WarningsExact identifier
application number: M020
Neutrogena MINERAL UV TINT FACE LIGHT SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLCe7af4f58-90c8-2987-e053-2995a90a416b2024-11-13WarningsExact identifier
application number: M020
Neutrogena Healthy Skin Liquid Makeup Broad Spectrum SPF 20 - Classic Ivory 10TITANIUM DIOXIDEKenvue Brands LLC143e0a1d-305f-9015-e063-6294a90aa0252024-11-13WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC05cb5a91-205f-b652-e063-6294a90a06642024-11-13WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Dry-Touch Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLC18e40353-5c95-4d64-e063-6394a90a017c2024-11-12WarningsExact identifier
application number: M020
Neutrogena Healthy Skin Liquid Makeup SPF 20 - Classic Ivory 10TITANIUM DIOXIDEKenvue Brands LLCe0ed4537-8146-45e8-e053-2995a90ac51b2024-11-12WarningsExact identifier
application number: M020
Arbonne AgeWell Moisture Restoring Broad Spectrum SPF 15 SunscreenZINC OXIDEArbonne International, LLCc172f793-3f7a-47b3-9db1-58487b8ad66c2024-11-12WarningsExact identifier
application number: M020
Hello Sunday The Everyday One Face Moisturiser SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKao USA Inc.0c7e1aa2-7054-435d-e063-6394a90a2d082024-11-12WarningsExact identifier
application number: M020
ZO Skin Health Sunscreen Plus Powder Broad-Spectrum SPF 45ZINC OXIDEZO Skin Health, Inc.be3c7ef2-dd08-0f1a-e053-2995a90ae14c2024-11-12WarningsExact identifier
application number: M020
TiZO Photoceutical AM Replenish - TintedZINC OXIDEFallien Cosmeceuticals, LTDfbafa468-fce0-4597-bcb0-a816dc71ec7c2024-11-12WarningsExact identifier
application number: M020
Sunscreen Plus Powder Broad-Spectrum SPF 45ZINC OXIDEZO Skin Health, Inc.beb0b43b-a90d-05ae-e053-2995a90a1d8e2024-11-12WarningsExact identifier
application number: M020
Neutrogena Healthy Skin Anti-Aging Perfector Sunscreen Broad Spectrum SPF 20 Ivory to Fair 10OCTINOXATE AND OCTISALATEKenvue Brands LLC0e489dec-9c7e-48c1-98cb-1aec91884a162024-11-11WarningsExact identifier
application number: M020
Neutrogena Revitalizing Lip Balm SPF 20 - Sheeer Shimmer 10OCTINOXATE AND OXYBENZONEKenvue Brands LLCe77c07d4-4e64-4000-9e7a-963aa6c6448c2024-11-11WarningsExact identifier
application number: M020
Neutrogena Sheer Zinc DRY-TOUCH Sunscreen Broad Spectrum SPF50ZINC OXIDEKenvue Brands LLC54a3b677-4510-4191-8386-ccdd10ccfcaa2024-11-11WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 4.5WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior504d8118-f84d-4f3f-abd1-463f3780a2cb2024-11-11WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 2WOOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior0d4e667a-cf93-4f6d-8565-ecfa9a18cfbf2024-11-11WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53675-187-00536750187004.8 g in 1 TUBE (53675-187-00) 4.8 g2020-05-150000-00-00NoNoCurrent