Mineral Sunscreen Lip Balm SPF 15

Product NDC
53675-184
11-digit product format
536750184
Labeler code
53675
Product ID
53675-184_0986172c-ce4b-2106-e063-6394a90ab452
Type
HUMAN OTC DRUG
Nonproprietary name
TITANIUM DIOXIDE, ZINC OXIDE
Dosage form
LIPSTICK
Route
TOPICAL
Labeler
Aruba Aloe Balm NV
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-01-05
Substance
ZINC OXIDE
Active strength
80 mg/g
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Mineral Sunscreen Lip Balm SPF 15
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE80 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSOI2LOH54Z

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
53675-184-17Mineral Sunscreen Lip Balm SPF 154.8 g in 1 APPLICATORLIPSTICK4.82

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53675-184MINERAL SUNSCREEN LIP BALM SPF 15 (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [ARUBA ALOE BALM NV]2Current NDC, Legacy NDC, 1 package rows20231108_ac87fe83-dd4c-44c8-9ad8-3416fa88d71e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53675-184-17536750184174.8 g in 1 APPLICATOR (53675-184-17) 4.8 g2019-01-050000-00-00NoNoCurrent