NDC 71070-868

JACKET SPF-50 Broad Spectrum Sunscreen

Zinc Oxide, Homosalate, Octisalate, Octocrylene

JACKET SPF-50 Broad Spectrum Sunscreen is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Balshi Md Dermaceuticals. The primary component is Zinc Oxide; Homosalate; Octisalate; Octocrylene.

• Product ID: 71070-868_86906c21-b035-103f-e053-2991aa0a9209
• NDC: 71070-868
• Product Type: Human Otc Drug
• Proprietary Name: JACKET SPF-50 Broad Spectrum Sunscreen
• Generic Name: Zinc Oxide, Homosalate, Octisalate, Octocrylene
• Dosage Form: Lotion
• Route of Administration: TOPICAL
• Marketing Start Date: 2019-04-15
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part352
• Labeler Name: BALSHI MD DERMACEUTICALS
• Substance Name: ZINC OXIDE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
• Active Ingredient Strength: 60 mg/mL; mg/mL; mg/mL; mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 71070-868-04

120 mL in 1 TUBE (71070-868-04)

• Marketing Start Date: 2019-04-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 71070-868-04 [71070086804]

JACKET SPF-50 Broad Spectrum Sunscreen LOTION

• Marketing Category: OTC monograph not final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2019-04-15

Drug Details

Active Ingredients

Ingredient	Strength
ZINC OXIDE	60 mg/mL

OpenFDA Data

• SPL SET ID: fcc45edd-098c-4f27-9712-0db36cfa0fdc
• Manufacturer:
  • BALSHI MD DERMACEUTICALS
• UNII:
  • SOI2LOH54Z
  • 4X49Y0596W
  • 5A68WGF6WM
  • V06SV4M95S