Florida Suncare

Product NDC
13630-0235
Requested package NDC
13630-0235-4
11-digit product format
136300235
Labeler code
13630
Product ID
13630-0235_dd2c1b9a-00a6-f9c0-e053-2a95a90ac6b0
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone,Octisalate, Octocrylene
Dosage form
SPRAY
Route
TOPICAL
Labeler
Prime Packaging, Inc.
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2017-08-18
Marketing end
0000-00-00
Substance
AVOBENZONE; OCTISALATE; OCTOCRYLENE
Active strength
16 mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13630-0235-413630023504191 mL in 1 CAN (13630-0235-4) 191 ml2017-08-180000-00-00NoNoCurrent