NDC 42361-158

OS SILKY SUN CUSHION Broad Spectrum SPF 50

Ensulizole, Octinoxate, Octocrylene, Titanium Dioxide, Zinc Oxide

OS SILKY SUN CUSHION Broad Spectrum SPF 50 is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Dong Sung Bio Pharm. Co., Ltd.. The primary component is Octinoxate; Titanium Dioxide; Zinc Oxide; Octocrylene; Ensulizole.

• Product ID: 42361-158_89bbf6d9-592b-f7ab-e053-2995a90a42e1
• NDC: 42361-158
• Product Type: Human Otc Drug
• Proprietary Name: OS SILKY SUN CUSHION Broad Spectrum SPF 50
• Generic Name: Ensulizole, Octinoxate, Octocrylene, Titanium Dioxide, Zinc Oxide
• Dosage Form: Lotion
• Route of Administration: TOPICAL
• Marketing Start Date: 2019-05-25
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part352
• Labeler Name: Dong Sung Bio Pharm. Co., Ltd.
• Substance Name: OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE; OCTOCRYLENE; ENSULIZOLE
• Active Ingredient Strength: 1 g/14g; g/14g; g/14g; g/14g; g/14g
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 42361-158-01

1 CASE in 1 CARTON (42361-158-01) > 14 g in 1 CASE

• Marketing Start Date: 2019-05-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 42361-158-01 [42361015801]

OS SILKY SUN CUSHION Broad Spectrum SPF 50 LOTION

• Marketing Category: OTC monograph not final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2019-05-25

Drug Details

Active Ingredients

Ingredient	Strength
OCTINOXATE	1.036 g/14g

OpenFDA Data

• SPL SET ID: 89bc4ec2-7598-2ac1-e053-2995a90a3c6d
• Manufacturer:
  • Dong Sung Bio Pharm. Co., Ltd.
• UNII:
  • 15FIX9V2JP
  • SOI2LOH54Z
  • 5A68WGF6WM
  • 4Y5P7MUD51
  • 9YQ9DI1W42

NDC Crossover Matching brand name "OS SILKY SUN CUSHION Broad Spectrum SPF 50" or generic name "Ensulizole, Octinoxate, Octocrylene, Titanium Dioxide, Zinc Oxide"

NDC	Brand Name	Generic Name
42361-152	ac care Bees Sun Protection	Ensulizole, Octinoxate, Octocrylene, Titanium Dioxide, Zinc Oxide
82070-010	ac care Bees Sun Protection	Ensulizole, Octinoxate, Octocrylene, Titanium Dioxide, Zinc Oxide
42361-155	Bling Day Everyday Sunscreen	Ensulizole, Octinoxate, Octocrylene, Titanium Dioxide, Zinc Oxide
82070-020	Bling Day Everyday Sunscreen	Ensulizole, Octinoxate, Octocrylene, Titanium Dioxide, Zinc Oxide
42361-158	OS SILKY SUN CUSHION	Ensulizole, Octinoxate, Octocrylene, Titanium Dioxide, Zinc Oxide
82070-030	OS SILKY SUN CUSHION	Ensulizole, Octinoxate, Octocrylene, Titanium Dioxide, Zinc Oxide