FDA.reportPublic FDA data

Australian Sands SPF 50 Sunscreen

Product NDC
72839-391
11-digit product format
728390391
Labeler code
72839
Product ID
72839-391_29a5e538-8ed5-677a-e063-6394a90a4cd6
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%
Dosage form
SPRAY
Route
TOPICAL
Labeler
Derma Care Research Labs, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-10-12
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
3; 15; 5; 10 g/100g; g/100g; g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Australian Sands SPF 50 Sunscreen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE3 g/100g
HOMOSALATE15 g/100g
OCTISALATE5 g/100g
OCTOCRYLENE10 g/100g

Harmonized Identifiers#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72839-391-06Australian Sands SPF 50 Sunscreen170 g in 1 CANSPRAY1702

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72839-391AUSTRALIAN SANDS SPF 50 SUNSCREEN (AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%) SPRAY [DERMA CARE RESEARCH LABS, LLC]2Current NDC, 1 package rows20241222_f886a02f-c043-b281-e053-6294a90af746.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72839-391-0672839039106170 g in 1 CAN (72839-391-06) 170 g2022-10-12NoNoHistorical