NDC 61352-004

Total Sun Protection

Octinoxate, Octisalate, Oxybenzone, Zinc Oxide

Total Sun Protection is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Cosmed Dermaceuticals, Inc.. The primary component is Octinoxate; Octisalate; Oxybenzone; Zinc Oxide.

Product ID61352-004_41213645-a51b-41f6-bdca-e92df5bd2a8c
NDC61352-004
Product TypeHuman Otc Drug
Proprietary NameTotal Sun Protection
Generic NameOctinoxate, Octisalate, Oxybenzone, Zinc Oxide
Dosage FormLotion
Route of AdministrationTOPICAL
Marketing Start Date2013-08-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart352
Labeler NameCosmed Dermaceuticals, Inc.
Substance NameOCTINOXATE; OCTISALATE; OXYBENZONE; ZINC OXIDE
Active Ingredient Strength75 mg/g; mg/g; mg/g; mg/g
Pharm ClassesCopper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 61352-004-01

127.6 g in 1 BOTTLE, PLASTIC (61352-004-01)
Marketing Start Date2018-02-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61352-004-01 [61352000401]

Total Sun Protection LOTION
Marketing CategoryOTC monograph final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-02-13

Drug Details

Active Ingredients

IngredientStrength
OCTINOXATE75 mg/g

OpenFDA Data

SPL SET ID:dbb16ef1-ab8c-4e71-a2a2-a507d104ff0f
Manufacturer
UNII

NDC Crossover Matching brand name "Total Sun Protection" or generic name "Octinoxate, Octisalate, Oxybenzone, Zinc Oxide"

NDCBrand NameGeneric Name
61352-004Total Sun ProtectionOctinoxate, Octisalate, Oxybenzone, Zinc Oxide
59779-301age renewal firming and hydrating moisturizerOctinoxate, Octisalate, Oxybenzone, Zinc Oxide
68634-0031age renewal firming and hydrating moisturizerOctinoxate, Octisalate, Oxybenzone, Zinc Oxide

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