NDC 76446-008

Extreme (UVA/UVB) SPF 33

Ethylhexyl Methoxycinnamate, Butyl Methoxydibenzoylmethane, Octocrylene

Extreme (UVA/UVB) SPF 33 is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Anna Lotan Ltd.. The primary component is Octinoxate; Avobenzone; Octocrylene.

Product ID76446-008_33335cf4-3bb2-70c8-e054-00144ff8d46c
NDC76446-008
Product TypeHuman Otc Drug
Proprietary NameExtreme (UVA/UVB) SPF 33
Generic NameEthylhexyl Methoxycinnamate, Butyl Methoxydibenzoylmethane, Octocrylene
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2016-05-19
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart352
Labeler NameAnna Lotan Ltd.
Substance NameOCTINOXATE; AVOBENZONE; OCTOCRYLENE
Active Ingredient Strength75 mg/mL; mg/mL; mg/mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 76446-008-75

75 mL in 1 BOTTLE (76446-008-75)
Marketing Start Date2016-05-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 76446-008-75 [76446000875]

Extreme (UVA/UVB) SPF 33 CREAM
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-05-19
Marketing End Date2019-08-31

Drug Details

Active Ingredients

IngredientStrength
OCTINOXATE75 mg/mL

OpenFDA Data

SPL SET ID:3e7a8cd1-61cf-4555-bbb9-8d153dbb0c97
Manufacturer
UNII

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