Drug Enforcement D-0512-2025

cGMP deviations

Status

Ongoing

Classification

Class II

Report Date

July 16, 2025

Termination Date

Product Information

Product description
B Natural Organics, Organic Sunscreen, Broad Spectrum, SPF 30, 25% non-nano Zinc Oxide, a) Nude Tint Mineral Formula for Face and Body, 4 oz. (120 ML) per bottle. NDC: 73369-1002-2; b) Tint Free Mineral Formula for Face and Body, 4 oz. (120 ML) per bottle. NDC: 73369-1001-2; c) Tan Tint Mineral Formula for Face and Body, 4 oz. (120 ML) per bottle. NDC: 73369-1003-2.
Product quantity
204 tubes
Reason for recall
cGMP deviations
Recall initiation reason
Initial firm notification
Letter
Distribution pattern
NJ, FL, MI

Location & Firm

Recalling firm
KABANA SKIN CARE
Address
685 S Arthur Ave Unit 9b, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-0512-2025
Event ID
96853
Recall initiation date
March 12, 2025
Center classification date
July 10, 2025
Code info
Lots: a) 410-001, Exp 10/31/2027 b) 404-003, Exp 04/30/2027 c) 404-001, Exp 04/30/2027
More code info