ZO Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 50

Product NDC
42851-055
11-digit product format
428510055
Labeler code
42851
Product ID
42851-055_25df0034-2b20-a2af-e063-6394a90affe7
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form
LOTION
Route
TOPICAL
Labeler
ZO Skin Health, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-06-01
Marketing end
2026-11-01
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
30; 100; 50; 100 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ZO Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 50

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/mL
HOMOSALATE100 mg/mL
OCTISALATE50 mg/mL
OCTOCRYLENE100 mg/mL

Harmonized Identifiers#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42851-055-20ZO Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 5020 mL in 1 TUBELOTION206
42851-055-20ZO Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 501 in 1 CARTONLOTION16
42851-055-45ZO Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 5045 mL in 1 TUBELOTION456
42851-055-45ZO Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 501 in 1 CARTONLOTION16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42851-055ZO SKIN HEALTH SMART TONE BROAD-SPECTRUM SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [ZO SKIN HEALTH, INC.]6Current NDC, Legacy NDC, 4 package rows20241107_cda67d41-d063-4936-a6b9-23376304eb42.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42851-055-20428510055201 TUBE in 1 CARTON (42851-055-20) / 20 mL in 1 TUBE1 tube2022-06-012026-11-01NoNoCurrent
42851-055-45428510055451 TUBE in 1 CARTON (42851-055-45) / 45 mL in 1 TUBE1 tube2022-06-012026-11-01NoNoCurrent