ZO Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 50

Product NDC
42851-096
11-digit product format
428510096
Labeler code
42851
Product ID
42851-096_261d72c0-ea75-2024-e063-6394a90a65b9
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
2024-04-19
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
30; 68; 50; 100 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ZO Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 50
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/mL
HOMOSALATE68 mg/mL
OCTISALATE50 mg/mL
OCTOCRYLENE100 mg/mL

Harmonized Identifiers#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42851-096-20ZO Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 501 in 1 CARTONLOTION12
42851-096-20ZO Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 5045 mL in 1 TUBELOTION452
42851-096-45ZO Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 501 in 1 CARTONLOTION12
42851-096-45ZO Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 5045 mL in 1 TUBELOTION452

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42851-096ZO SKIN HEALTH SMART TONE BROAD-SPECTRUM SUNSCREEN SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [ZO SKIN HEALTH, INC.]2Current NDC, 4 package rows20241105_1560a6b6-8d4a-6942-e063-6294a90a4a44.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42851-096-20428510096201 TUBE in 1 CARTON (42851-096-20) / 45 mL in 1 TUBE1 tube2024-04-19NoNoCurrent
42851-096-45428510096451 TUBE in 1 CARTON (42851-096-45) / 45 mL in 1 TUBE1 tube2024-04-19NoNoCurrent