NDC 76224-101

SPF 15 Self Tanner

Octinoxate,oxybenzone

SPF 15 Self Tanner is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Whish Body Holdings Inc. The primary component is Octinoxate; Oxybenzone.

• Product ID: 76224-101_08b50aa0-79e9-4d93-a3bc-bf61410f21d4
• NDC: 76224-101
• Product Type: Human Otc Drug
• Proprietary Name: SPF 15 Self Tanner
• Generic Name: Octinoxate,oxybenzone
• Dosage Form: Lotion
• Route of Administration: TOPICAL
• Marketing Start Date: 2011-05-25
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part352
• Labeler Name: Whish Body Holdings Inc
• Substance Name: OCTINOXATE; OXYBENZONE
• Active Ingredient Strength: 8 mL/100mL; mL/100mL
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 76224-101-02

1 BOTTLE in 1 BOX (76224-101-02) > 150 mL in 1 BOTTLE (76224-101-01)

• Marketing Start Date: 2011-05-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 76224-101-01 [76224010101]

SPF 15 Self Tanner LOTION

• Marketing Category: OTC monograph not final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2011-05-25

NDC 76224-101-02 [76224010102]

SPF 15 Self Tanner LOTION

• Marketing Category: OTC monograph not final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2011-05-25
• Inactivation Date: 2019-10-29

Drug Details

Active Ingredients

Ingredient	Strength
OCTINOXATE	7.5 mL/100mL

OpenFDA Data

• SPL SET ID: b598d34a-3b86-4b58-9b19-025fcf3a82dd
• Manufacturer:
  • Whish Body Holdings Inc
• UNII:
  • 95OOS7VE0Y
  • 4Y5P7MUD51