NDC 65449-001

Dermatone Sunscreen SPF 30

Avobenzone 3.00% Homosalate 10.00% Octisalate 5.00% Octocrylene 10.00%

Dermatone Sunscreen SPF 30 is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Beaumont Products. The primary component is Avobenzone; Homosalate; Octisalate; Octocrylene.

• Product ID: 65449-001_6a6ab2d6-6dc3-4d78-8d0e-99f5e5668c7d
• NDC: 65449-001
• Product Type: Human Otc Drug
• Proprietary Name: Dermatone Sunscreen SPF 30
• Generic Name: Avobenzone 3.00% Homosalate 10.00% Octisalate 5.00% Octocrylene 10.00%
• Dosage Form: Lotion
• Route of Administration: TOPICAL
• Marketing Start Date: 2016-12-27
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part352
• Labeler Name: Beaumont Products
• Substance Name: AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
• Active Ingredient Strength: 3 g/100mL; g/100mL; g/100mL; g/100mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 65449-001-01

30 mL in 1 TUBE (65449-001-01)

• Marketing Start Date: 2016-12-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 65449-001-01 [65449000101]

Dermatone Sunscreen SPF 30 LOTION

• Marketing Category: OTC monograph not final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2016-12-27
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
AVOBENZONE	3 g/100mL

OpenFDA Data

• SPL SET ID: e3760253-ce9a-49bd-b646-03e443c514df
• Manufacturer:
  • Beaumont Products
• UNII:
  • G63QQF2NOX
  • 4X49Y0596W
  • 5A68WGF6WM
  • V06SV4M95S

NDC Crossover Matching brand name "Dermatone Sunscreen SPF 30" or generic name "Avobenzone 3.00% Homosalate 10.00% Octisalate 5.00% Octocrylene 10.00%"

NDC	Brand Name	Generic Name
65449-001	Dermatone Sunscreen SPF 30	Avobenzone 3.00% Homosalate 10.00% Octisalate 5.00% Octocrylene 10.00%
69039-568	Sunscreen SPF 70	Avobenzone 3.00% Homosalate 10.00% Octisalate 5.00% Octocrylene 10.00%