Drug Information

Product NDC: 69423-195

Proprietary Name: Olay Complete UV 365 Daily Moisturizer Normal

Non Proprietary Name: Avobenzone, Homosalate, Octisalate, and Octocrylene

Active Ingredient(s):
  • 3 g/100mL AVOBENZONE;
  • 4 g/100mL HOMOSALATE;
  • 4.5 g/100mL OCTISALATE;
  • 2.6 g/100mL OCTOCRYLENE

Administration Route(s): TOPICAL

Dosage Form(s): LOTION

Labeler Information

Labeler Name: The Procter & Gamble Manufacturing Company
Product Type: HUMAN OTC DRUG
FDA Application Number: part352
Start Marketing Date:9/11/2017

Package Information

No. Package Code Package Description Billing Unit
169423-195-121 BOTTLE, PLASTIC in 1 CARTON (69423-195-12) > 120 mL in 1 BOTTLE, PLASTIC
269423-195-171 BOTTLE, PLASTIC in 1 CARTON (69423-195-17) > 177 mL in 1 BOTTLE, PLASTIC

NDC Record

Field Name Field Value Definition
PRODUCT NDC69423-195The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN OTC DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMEOlay Complete UV 365 Daily Moisturizer NormalThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PROPRIETARY NAME SUFFIXBroad Spectrum SPF 15A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.
NON PROPRIETARY NAMEAvobenzone, Homosalate, Octisalate, and OctocryleneThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMELOTIONThe translation of the dosage form Code submitted by the firm.
ROUTE NAMETOPICALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE9/11/2017This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEOTC MONOGRAPH NOT FINALProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERpart352This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEThe Procter & Gamble Manufacturing CompanyName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEAVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENEThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
ACTIVE INGRED UNITg/100mL; g/100mL; g/100mL; g/100mL 

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This page was last updated on: 7/3/2020