NDC 66428-002

TheradermSPF 43 SPF 43

Zinc Oxide, Octinoxate, Octisalate

TheradermSPF 43 SPF 43 is a Topical Emulsion in the Human Otc Drug category. It is labeled and distributed by Therapon Skin Health, Lp. The primary component is Zinc Oxide; Octinoxate; Octisalate.

• Product ID: 66428-002_a9bbadd5-6e2d-4221-b508-a9719779b3ce
• NDC: 66428-002
• Product Type: Human Otc Drug
• Proprietary Name: TheradermSPF 43 SPF 43
• Generic Name: Zinc Oxide, Octinoxate, Octisalate
• Dosage Form: Emulsion
• Route of Administration: TOPICAL
• Marketing Start Date: 2012-01-20
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part352
• Labeler Name: Therapon Skin Health, LP
• Substance Name: ZINC OXIDE; OCTINOXATE; OCTISALATE
• Active Ingredient Strength: 8 mL/100mL; mL/100mL; mL/100mL
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 66428-002-02

1 TUBE in 1 BOX (66428-002-02) > 90 mL in 1 TUBE

• Marketing Start Date: 2012-01-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 66428-002-02 [66428000202]

TheradermSPF 43 SPF 43 EMULSION

• Marketing Category: OTC monograph final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2012-01-20
• Inactivation Date: 2019-11-13

NDC 66428-002-01 [66428000201]

TheradermSPF 43 SPF 43 EMULSION

• Marketing Category: OTC monograph final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2012-01-20
• Marketing End Date: 2012-01-24

Drug Details

Active Ingredients

Ingredient	Strength
ZINC OXIDE	7.5 mL/100mL

OpenFDA Data

• SPL SET ID: d83f0f88-8112-47dc-9bc5-c56f86dec51a
• Manufacturer:
  • Therapon Skin Health, LP
• UNII:
  • SOI2LOH54Z
  • 4X49Y0596W
  • 4Y5P7MUD51

NDC Crossover Matching brand name "TheradermSPF 43 SPF 43" or generic name "Zinc Oxide, Octinoxate, Octisalate"

NDC	Brand Name	Generic Name
13733-019	MISSHA TIME REVOLUTION WHITE CURE UV SUN PROTECTOR	ZINC OXIDE, OCTINOXATE, OCTISALATE
62362-129	Neova DNA Damage Control - Active	Zinc Oxide, Octinoxate, Octisalate
62362-139	Neova DNA Damage Control - Everyday	Zinc Oxide, Octinoxate, Octisalate
51346-439	PROVENCE AIR SKIN FIT PACT 02 NATURAL BEIGE	ZINC OXIDE, OCTINOXATE, OCTISALATE
42521-2930	SkinTx UV Pro Broad Spectrum SPF30	ZINC OXIDE, OCTINOXATE, OCTISALATE
66428-002	TheradermSPF 43	Zinc Oxide, Octinoxate, Octisalate