NDC 70341-601

the SAEM Foundation 02 Medium

Titanium Dioxide, Zinc Oxide, Octinoxate, Octisalate

the SAEM Foundation 02 Medium is a Topical Powder in the Human Otc Drug category. It is labeled and distributed by The Saem International Co., Ltd.. The primary component is Titanium Dioxide; Zinc Oxide; Octinoxate; Octisalate.

• Product ID: 70341-601_3eaf86c8-8555-4761-96a2-249ef314b38f
• NDC: 70341-601
• Product Type: Human Otc Drug
• Proprietary Name: the SAEM Foundation 02 Medium
• Generic Name: Titanium Dioxide, Zinc Oxide, Octinoxate, Octisalate
• Dosage Form: Powder
• Route of Administration: TOPICAL
• Marketing Start Date: 2018-05-01
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part352
• Labeler Name: The Saem International Co., Ltd.
• Substance Name: TITANIUM DIOXIDE; ZINC OXIDE; OCTINOXATE; OCTISALATE
• Active Ingredient Strength: 4 g/30mL; g/30mL; g/30mL; g/30mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 70341-601-02

1 CONTAINER in 1 CARTON (70341-601-02) > 30 mL in 1 CONTAINER (70341-601-01)

• Marketing Start Date: 2018-05-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70341-601-01 [70341060101]

the SAEM Foundation 02 Medium POWDER

• Marketing Category: OTC monograph not final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2018-05-01
• Marketing End Date: 2019-11-01

NDC 70341-601-02 [70341060102]

the SAEM Foundation 02 Medium POWDER

• Marketing Category: OTC monograph not final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2018-05-01
• Marketing End Date: 2019-11-01

Drug Details

Active Ingredients

Ingredient	Strength
TITANIUM DIOXIDE	3.84 g/30mL

OpenFDA Data

• SPL SET ID: e57dfb79-1a04-4dad-ae3d-f0934552bd5d
• Manufacturer:
  • The Saem International Co., Ltd.
• UNII:
  • 15FIX9V2JP
  • SOI2LOH54Z
  • 4X49Y0596W
  • 4Y5P7MUD51

NDC Crossover Matching brand name "the SAEM Foundation 02 Medium" or generic name "Titanium Dioxide, Zinc Oxide, Octinoxate, Octisalate"

NDC	Brand Name	Generic Name
70341-601	the SAEM Foundation 02 Medium	Titanium Dioxide, Zinc Oxide, Octinoxate, Octisalate
69769-102	DD TZ FORTE	TITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE, OCTISALATE
49404-141	Dr.Jart Premium Beauty Balm 03 Deep	Titanium Dioxide, Zinc Oxide, Octinoxate, Octisalate
70341-600	the SAEM Foundation 01 Light	Titanium Dioxide, Zinc Oxide, Octinoxate, Octisalate
70341-602	the SAEM Foundation 03 Medium Deep	Titanium Dioxide, Zinc Oxide, Octinoxate, Octisalate