FDA.reportPublic FDA data

SPF30 unseen sunscreen

Product NDC
82953-046
11-digit product format
829530046
Labeler code
82953
Product ID
82953-046_398b9d05-b767-ed64-e063-6294a90a492c
Type
HUMAN OTC DRUG
Nonproprietary name
butyl Methoxydibenzoylmeth, ethylhexyl salicylate, homosalate, octocrylene
Dosage form
CREAM
Route
TOPICAL
Labeler
Cosmuses Cosmetics (Ningbo) Co., Ltd.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-07-10
Substance
BUTYL METHOXYDIBENZOYLMETHANE; ETHYLHEXYL SALICYLATE; HOMOSALATE; OCTOCRYLENE
Active strength
3; 5; 10; 10 g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SPF30 unseen sunscreen
Brand name suffix
01
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUTYL METHOXYDIBENZOYLMETHANE3 g/100mL
ETHYLHEXYL SALICYLATE5 g/100mL
HOMOSALATE10 g/100mL
OCTOCRYLENE10 g/100mL

Harmonized Identifiers#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82953-046-01SPF30 unseen sunscreen0110 mL in 1 TUBECREAM101
82953-046-02SPF30 unseen sunscreen0130 mL in 1 TUBECREAM301
82953-046-03SPF30 unseen sunscreen0150 mL in 1 TUBECREAM501
82953-046-04SPF30 unseen sunscreen0160 mL in 1 TUBECREAM601

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82953-046-018295300460110 mL in 1 TUBE (82953-046-01) 10 ml2025-07-10NoNoHistorical
82953-046-028295300460230 mL in 1 TUBE (82953-046-02) 30 ml2025-07-10NoNoHistorical
82953-046-038295300460350 mL in 1 TUBE (82953-046-03) 50 ml2025-07-10NoNoHistorical
82953-046-048295300460460 mL in 1 TUBE (82953-046-04) 60 ml2025-07-10NoNoHistorical