NDC 76138-213

5281 sunscreen

Octocrylene, Titanium Dioxide, Octisalate

5281 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 ID76138-213_b7839ce3-ace1-46f3-b795-8c74775fe8ee
NDC76138-213
Product TypeHuman Otc Drug
Proprietary Name5281 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 76138-213-05

15 mL in 1 BOTTLE, PLASTIC (76138-213-05)
Marketing Start Date2018-06-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 76138-213-05 [76138021305]

5281 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:a43e2151-808b-4330-9c41-996669264290
Manufacturer
UNII

NDC Crossover Matching brand name "5281 sunscreen" or generic name "Octocrylene, Titanium Dioxide, Octisalate"

NDCBrand NameGeneric Name
76138-2075281 sunscreenOctinoxate, Octisalate, Oxybenzone, Titanium dioxide
76138-2135281 sunscreenOctocrylene, Titanium dioxide, Octisalate
76138-2195281 SUNSCREENAvobenzone, Homosalate, Octocrylene, Octisalate
76138-2165283 sunscreenOctocrylene, Titanium dioxide, Octisalate
76138-2155298 sunscreenOctocrylene, Titanium dioxide, Octisalate
76138-2175299 sunscreenOctocrylene, Titanium dioxide, Octisalate
76138-2145407 sunscreenOctocrylene, Titanium dioxide, Octisalate
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