NDC 40046-0036

PREP (plus) PRIME BEAUTY BALM SPF 35

Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide, Zinc Oxide

PREP (plus) PRIME BEAUTY BALM SPF 35 is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Make-up Art Cosmetics. The primary component is Octinoxate; Octisalate; Oxybenzone; Titanium Dioxide; Zinc Oxide.

• Product ID: 40046-0036_e9ac9caf-34b9-4218-ae0a-fa2182c2898f
• NDC: 40046-0036
• Product Type: Human Otc Drug
• Proprietary Name: PREP (plus) PRIME BEAUTY BALM SPF 35
• Generic Name: Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide, Zinc Oxide
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2010-04-01
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part352
• Labeler Name: MAKE-UP ART COSMETICS
• Substance Name: OCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE; ZINC OXIDE
• Active Ingredient Strength: 7 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 40046-0036-1

1 TUBE in 1 CARTON (40046-0036-1) > 30 mL in 1 TUBE (40046-0036-2)

• Marketing Start Date: 2010-04-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 40046-0036-2 [40046003602]

PREP (plus) PRIME BEAUTY BALM SPF 35 CREAM

• Marketing Category: OTC monograph not final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2010-04-01

NDC 40046-0036-1 [40046003601]

PREP (plus) PRIME BEAUTY BALM SPF 35 CREAM

• Marketing Category: OTC monograph not final
• Application Number: part352
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2010-04-01
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
OCTINOXATE	7.4 mL/100mL

OpenFDA Data

• SPL SET ID: 390daee0-d16b-466a-81df-c30d130f833d
• Manufacturer:
  • MAKE-UP ART COSMETICS
• UNII:
  • 15FIX9V2JP
  • SOI2LOH54Z
  • 95OOS7VE0Y
  • 4X49Y0596W
  • 4Y5P7MUD51

NDC Crossover Matching brand name "PREP (plus) PRIME BEAUTY BALM SPF 35" 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