FDA.reportPublic FDA data

cle de peau BEAUTE Protective Day

Product NDC
58411-953
11-digit product format
584110953
Labeler code
58411
Product ID
58411-953_4ba70b99-a469-5452-e063-6294a90ae3bd
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Octinoxate, Octocrylene
Dosage form
EMULSION
Route
TOPICAL
Labeler
Shiseido Americas Corporation
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-02
Substance
AVOBENZONE; OCTINOXATE; OCTOCRYLENE
Active strength
3.25; 6.38; 6.51 g/125mL; g/125mL; g/125mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
cle de peau BEAUTE Protective Day
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE3.25 g/125mL
OCTINOXATE6.38 g/125mL
OCTOCRYLENE6.51 g/125mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG63QQF2NOX, 4Y5P7MUD51, 5A68WGF6WM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58411-953-10cle de peau BEAUTE Protective Day125 mL in 1 BOTTLE, GLASSEMULSION1254
58411-953-10cle de peau BEAUTE Protective Day1 in 1 BOXEMULSION14
58411-953-11cle de peau BEAUTE Protective Day12 mL in 1 BOTTLE, PLASTICEMULSION124
58411-953-11cle de peau BEAUTE Protective Day1 in 1 BOXEMULSION14
58411-953-12cle de peau BEAUTE Protective Day1 in 1 BOXEMULSION14
58411-953-12cle de peau BEAUTE Protective Day5 mL in 1 BOTTLE, PLASTICEMULSION54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
58411-953-10584110953101 BOTTLE, GLASS in 1 BOX (58411-953-10) / 125 mL in 1 BOTTLE, GLASS2025-12-11NoNoHistorical
58411-953-11584110953111 BOTTLE, PLASTIC in 1 BOX (58411-953-11) / 12 mL in 1 BOTTLE, PLASTIC2025-02-02NoNoHistorical
58411-953-12584110953121 BOTTLE, PLASTIC in 1 BOX (58411-953-12) / 5 mL in 1 BOTTLE, PLASTIC2025-02-02NoNoHistorical