NDC 69435-1804

XXL Sun Block SPF 50

Octinoxate, Octocrylene, Octisalate, Avobenzone, Homosalate, Titanium Dioxide Cream

XXL Sun Block SPF 50 is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Peer Pharma Ltd.. The primary component is Titanium Dioxide; Octocrylene; Octisalate; Avobenzone; Homosalate; Octinoxate.

Product ID69435-1804_6cf6cd4b-7be8-6bad-e053-2991aa0a2020
NDC69435-1804
Product TypeHuman Otc Drug
Proprietary NameXXL Sun Block SPF 50
Generic NameOctinoxate, Octocrylene, Octisalate, Avobenzone, Homosalate, Titanium Dioxide Cream
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2018-05-24
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart352
Labeler NamePeer Pharma Ltd.
Substance NameTITANIUM DIOXIDE; OCTOCRYLENE; OCTISALATE; AVOBENZONE; HOMOSALATE; OCTINOXATE
Active Ingredient Strength3 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 69435-1804-1

100 mL in 1 CONTAINER (69435-1804-1)
Marketing Start Date2018-05-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69435-1804-1 [69435180401]

XXL Sun Block SPF 50 CREAM
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-05-24

Drug Details

Active Ingredients

IngredientStrength
TITANIUM DIOXIDE3 g/100mL

OpenFDA Data

SPL SET ID:6cf6cd4b-7be7-6bad-e053-2991aa0a2020
Manufacturer
UNII

NDC Crossover Matching brand name "XXL Sun Block SPF 50" or generic name "Octinoxate, Octocrylene, Octisalate, Avobenzone, Homosalate, Titanium Dioxide Cream"

NDCBrand NameGeneric Name
69435-1804XXL Sun Block SPF 50Octinoxate, Octocrylene, Octisalate, Avobenzone, Homosalate, Titanium Dioxide cream
69435-1905XXL Sun Block SPF 50Octinoxate, Octocrylene, Octisalate, Avobenzone, Homosalate cream

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