Broad Spectrum SPF15 Very Water Resistant (80 Minutes) Sunscreen

Product NDC
53675-206
11-digit product format
536750206
Labeler code
53675
Product ID
53675-206_4a874b22-0b33-ad19-e063-6394a90a0d17
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE
Dosage form
CREAM
Route
TOPICAL
Labeler
Aruba Aloe Balm NV
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-06-02
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
30; 73.4; 50; 50 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Broad Spectrum SPF15 Very Water Resistant (80 Minutes) Sunscreen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/mL
HOMOSALATE73.4 mg/mL
OCTISALATE50 mg/mL
OCTOCRYLENE50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG63QQF2NOX, V06SV4M95S, 4X49Y0596W, 5A68WGF6WM

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53675-206-00Broad Spectrum SPF15 Very Water Resistant (80 Minutes) Sunscreen59 mL in 1 TUBECREAM592
53675-206-01Broad Spectrum SPF15 Very Water Resistant (80 Minutes) Sunscreen177 mL in 1 TUBECREAM1772

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53675-206BROAD SPECTRUM SPF15 VERY WATER RESISTANT (80 MINUTES) SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) CREAM [ARUBA ALOE BALM NV]1Current NDC, 2 package rows20231123_046465b7-ebad-4e57-838d-bbf8f7b7802d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53675-206-005367502060059 mL in 1 TUBE (53675-206-00) 59 ml2023-06-02NoNoCurrent
53675-206-0153675020601177 mL in 1 TUBE (53675-206-01) 177 ml2023-06-02NoNoCurrent