NDC 46783-223

Prismplus Broad-Spectrum Sunscreen SPF 43

Octinoxate, Octisalate, And Zinc Oxide

Prismplus Broad-Spectrum Sunscreen SPF 43 is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Merz North America, Inc. The primary component is Octinoxate; Octisalate; Zinc Oxide.

Product ID46783-223_1a7ed5ec-ea41-4705-a283-2b7f60790c3c
NDC46783-223
Product TypeHuman Otc Drug
Proprietary NamePrismplus Broad-Spectrum Sunscreen SPF 43
Generic NameOctinoxate, Octisalate, And Zinc Oxide
Dosage FormLotion
Route of AdministrationTOPICAL
Marketing Start Date2018-06-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart352
Labeler NameMerz North America, Inc
Substance NameOCTINOXATE; OCTISALATE; ZINC OXIDE
Active Ingredient Strength75 mg/mL; mg/mL; mg/mL
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 46783-223-04

4 mL in 1 TUBE (46783-223-04)
Marketing Start Date2019-06-15
NDC Exclude FlagN
Sample Package?Y

NDC SPL Data Element Entries

NDC 46783-223-15 [46783022315]

Prismplus Broad-Spectrum Sunscreen SPF 43 LOTION
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-06-01

NDC 46783-223-50 [46783022350]

Prismplus Broad-Spectrum Sunscreen SPF 43 LOTION
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-06-01

NDC 46783-223-04 [46783022304]

Prismplus Broad-Spectrum Sunscreen SPF 43 LOTION
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-06-15

Drug Details

Active Ingredients

IngredientStrength
OCTINOXATE75 mg/mL

OpenFDA Data

SPL SET ID:9980e0ac-6be6-40b5-822b-d500161f2131
Manufacturer
UNII

NDC Crossover Matching brand name "Prismplus Broad-Spectrum Sunscreen SPF 43" or generic name "Octinoxate, Octisalate, And Zinc Oxide"

NDCBrand NameGeneric Name
46783-223Prismplus Broad-Spectrum Sunscreen SPF 43OCTINOXATE, OCTISALATE, and ZINC OXIDE
59062-1207BabyGanics SunscreenOCTINOXATE, OCTISALATE, and ZINC OXIDE
59062-1210BabyGanics SunscreenOCTINOXATE, OCTISALATE, and ZINC OXIDE
59062-1238BabyGanics SunscreenOCTINOXATE, OCTISALATE, and ZINC OXIDE
59062-1247BabyGanics SunscreenOCTINOXATE, OCTISALATE, and ZINC OXIDE
11523-7301Coppertone KidsOctinoxate, Octisalate, and Zinc Oxide
11523-7300Coppertone Sensitive SkinOctinoxate, Octisalate, and Zinc Oxide
11523-7303Coppertone Sensitive SkinOctinoxate, octisalate, and zinc oxide
11523-7290Coppertone waterBABIES Pure and Simpleoctinoxate, octisalate, and zinc oxide
70605-029Principal Secret Reclaim Botanical (with SP) Radiant Recovery Day Broad Spectrum SPF 15Octinoxate, Octisalate, and Zinc Oxide
58443-0175SolScentsOctinoxate, Octisalate, and Zinc Oxide
69926-004Too Cool For SchoolOctinoxate, Octisalate, and Zinc Oxide

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