NDC 40046-0039

PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35

Octinoxate, Octisalate, Zinc Oxide, Oxybenzone

PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35 is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Makeup Art Cosmetics. The primary component is Octinoxate; Octisalate; Zinc Oxide; Oxybenzone; Titanium Dioxide.

Product ID40046-0039_8e82c4a4-fbc9-46bb-980e-31e302be7f7a
NDC40046-0039
Product TypeHuman Otc Drug
Proprietary NamePREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35
Generic NameOctinoxate, Octisalate, Zinc Oxide, Oxybenzone
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2011-04-01
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart352
Labeler NameMAKEUP ART COSMETICS
Substance NameOCTINOXATE; OCTISALATE; ZINC OXIDE; OXYBENZONE; TITANIUM DIOXIDE
Active Ingredient Strength7 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 40046-0039-1

1 TUBE in 1 CARTON (40046-0039-1) > 30 mL in 1 TUBE (40046-0039-2)
Marketing Start Date2011-04-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 40046-0039-1 [40046003901]

PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35 CREAM
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-04-01
Inactivation Date2020-01-31

NDC 40046-0039-2 [40046003902]

PREP AND PRIME FORTIFIED SKIN ENHANCER SPF 35 CREAM
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-04-01

Drug Details

Active Ingredients

IngredientStrength
OCTINOXATE7.4 mL/100mL

OpenFDA Data

SPL SET ID:a1b22e6f-5dde-48b0-86f2-305b1bc67c0c
Manufacturer
UNII

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