70281-212 NDC - OP PROTECT AND RENEW BODY SPF 45 (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTYL SALICYLATE, OXYBENZONE)

Drug Information

Product NDC: 70281-212

Proprietary Name: OP Protect and Renew Body SPF 45

Non Proprietary Name: Avobenzone, Homosalate, Octocrylene, Octyl Salicylate, Oxybenzone

Active Ingredient(s):
  • 3 g/100g AVOBENZONE;
  • 15 g/100g HOMOSALATE;
  • 2.35 g/100g OCTOCRYLENE;
  • 5 g/100g OCTISALATE;
  • 5 g/100g OXYBENZONE


Administration Route(s): TOPICAL

Dosage Form(s): LOTION

Labeler Information

Labeler Name: SolSkyn Personal Care LLC
Product Type: HUMAN OTC DRUG
FDA Application Number: part352
Marketing Category: OTC MONOGRAPH NOT FINAL
Start Marketing Date:9/15/2015

Package Information

No. Package Code Package Description Billing Unit
170281-212-14170 g in 1 CONTAINER (70281-212-14)

NDC Record

Field Name Field Value Definition
PRODUCT NDC70281-212The 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 NAMEOP Protect and Renew Body SPF 45The 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, Octocrylene, Octyl Salicylate, OxybenzoneThe 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 DATE9/15/2015This 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 NAMESolSkyn Personal Care LLCName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEAVOBENZONE; HOMOSALATE; OCTOCRYLENE; OCTISALATE; OXYBENZONEThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH3; 15; 2.35; 5; 5 
ACTIVE INGRED UNITg/100g; g/100g; g/100g; g/100g; g/100g 

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This page was last updated on: 8/16/2019