NDC 76138-215

5298 sunscreen

Octocrylene, Titanium Dioxide, Octisalate

5298 sunscreen is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Innovation Specialties. The primary component is Octocrylene; Titanium Dioxide; Octisalate.

Product ID76138-215_6e590ebe-f1f9-4b9e-96ed-d2f4ebf94197
NDC76138-215
Product TypeHuman Otc Drug
Proprietary Name5298 sunscreen
Generic NameOctocrylene, Titanium Dioxide, Octisalate
Dosage FormLotion
Route of AdministrationTOPICAL
Marketing Start Date2018-06-01
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart352
Labeler NameInnovation Specialties
Substance NameOCTOCRYLENE; TITANIUM DIOXIDE; OCTISALATE
Active Ingredient Strength9 g/100mL; g/100mL; g/100mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 76138-215-02

60 mL in 1 BOTTLE, PLASTIC (76138-215-02)
Marketing Start Date2018-06-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 76138-215-02 [76138021502]

5298 sunscreen LOTION
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-06-01

Drug Details

Active Ingredients

IngredientStrength
OCTOCRYLENE9 g/100mL

OpenFDA Data

SPL SET ID:07e8b370-0233-419a-9fea-e38ee73baabb
Manufacturer
UNII

NDC Crossover Matching brand name "5298 sunscreen" or generic name "Octocrylene, Titanium Dioxide, Octisalate"

NDCBrand NameGeneric Name
76138-2065298 sunscreenOctinoxate, Octisalate, Oxybenzone, Titanium Dioxide
76138-2155298 sunscreenOctocrylene, Titanium dioxide, Octisalate
76138-2205298 SUNSCREENAvobenzone, Homosalate, Octocrylene, Octisalate
76138-2135281 sunscreenOctocrylene, Titanium dioxide, Octisalate
76138-2165283 sunscreenOctocrylene, Titanium dioxide, Octisalate
76138-2175299 sunscreenOctocrylene, Titanium dioxide, Octisalate
76138-2145407 sunscreenOctocrylene, Titanium dioxide, Octisalate
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