82691-146 NDC - SOLEIL SUPERIEUR BROAD SPECTRUM SPF 50 SUNSCREEN US (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE)

Drug Information

  • Product NDC: 82691-146
  • Proprietary Name: Soleil Superieur Broad Spectrum SPF 50 Sunscreen US
  • Non Proprietary Name: AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
  • Active Ingredient(s): 30 mg/mL AVOBENZONE; 100 mg/mL HOMOSALATE; 50 mg/mL OCTISALATE; 26 mg/mL OCTOCRYLENE
  • Administration Route(s): TOPICAL
  • Dosage Form(s): CREAM

Labeler Information

Field Name Field Value
Labeler Name: RV Skincare LLC
Product Type: HUMAN OTC DRUG
FDA Application Number: M020
Marketing Category: OTC MONOGRAPH DRUG
Start Marketing Date:12/1/2017

Package Information

No. Package Code Package Description Billing Unit
182691-146-001 BOTTLE, PUMP in 1 CARTON (82691-146-00) / 50 mL in 1 BOTTLE, PUMP

NDC Record

Field Name Field Value Definition
PRODUCT NDC82691-146The 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 DRUGThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PROPRIETARY NAMESoleil Superieur Broad Spectrum SPF 50 Sunscreen USThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMECREAMProduct 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.
ROUTE NAMETOPICALThe 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.
START MARKETING DATE12/1/2017Name of Company corresponding to the labeler code segment of the Product NDC.
MARKETING CATEGORY NAMEOTC MONOGRAPH DRUGThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
APPLICATION NUMBERM020This is the date that the labeler indicates was the start of its marketing of the drug product.
LABELER NAMERV Skincare LLCThis is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
SUBSTANCE NAMEAVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENEAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH30; 100; 50; 26The 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.
ACTIVE INGRED UNITmg/mL; mg/mL; mg/mL; mg/mLThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

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This page was last updated on: 11/21/2025

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