NDC 49825-114

Bioelements Sun Diffusing Protector SPF 15

Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide, Zinc Oxide

Bioelements Sun Diffusing Protector SPF 15 is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Bioelements Inc.. The primary component is Octinoxate; Octisalate; Oxybenzone; Titanium Dioxide; Zinc Oxide.

• Product ID: 49825-114_19d7afa4-cd7c-4876-91f7-cf916fa73748
• NDC: 49825-114
• Product Type: Human Otc Drug
• Proprietary Name: Bioelements Sun Diffusing Protector SPF 15
• Generic Name: Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide, Zinc Oxide
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2009-01-01
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part352
• Labeler Name: Bioelements Inc.
• Substance Name: OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE
• Active Ingredient Strength: 8 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 49825-114-02

1 BOTTLE in 1 BOX (49825-114-02) > 177 mL in 1 BOTTLE (49825-114-01)

• Marketing Start Date: 2009-01-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 49825-114-01 [49825011401]

Bioelements Sun Diffusing Protector SPF 15 CREAM

• Marketing Category: OTC monograph not final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2009-01-01

NDC 49825-114-02 [49825011402]

Bioelements Sun Diffusing Protector SPF 15 CREAM

• Marketing Category: OTC monograph not final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2009-01-01
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
OCTINOXATE	7.5 mL/100mL

OpenFDA Data

• SPL SET ID: 6550938a-7299-4e4b-aafe-4d5ce13e79a5
• Manufacturer:
  • Bioelements Inc.
• UNII:
  • 15FIX9V2JP
  • SOI2LOH54Z
  • 95OOS7VE0Y
  • 4X49Y0596W
  • 4Y5P7MUD51

NDC Crossover Matching brand name "Bioelements Sun Diffusing Protector SPF 15" or generic name "Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide, Zinc Oxide"

NDC	Brand Name	Generic Name
68634-063	Age Renewal Firming	octinoxate, octisalate, oxybenzone, titanium dioxide, zinc oxide
69842-067	Age Renewal Firming and Hydrating Moisturizer SPF 30	octinoxate, octisalate, oxybenzone, titanium dioxide, zinc oxide
49825-114	Bioelements	Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide, Zinc Oxide
40046-0036	PREP (plus) PRIME BEAUTY BALM	OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE
68327-003	Skin Tint FX	OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE