NDC 54473-292

Sun Shades Lip Balm Mango Lime

Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 3%

Sun Shades Lip Balm Mango Lime is a Topical Stick in the Human Otc Drug category. It is labeled and distributed by Melaleuca Inc.. The primary component is Avobenzone; Octinoxate; Oxybenzone.

Product ID54473-292_68802872-fbda-6763-e053-2991aa0a7383
NDC54473-292
Product TypeHuman Otc Drug
Proprietary NameSun Shades Lip Balm Mango Lime
Generic NameAvobenzone 2.5%, Octinoxate 6%, Oxybenzone 3%
Dosage FormStick
Route of AdministrationTOPICAL
Marketing Start Date2018-01-01
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart352
Labeler NameMelaleuca Inc.
Substance NameAVOBENZONE; OCTINOXATE; OXYBENZONE
Active Ingredient Strength0 g/4.25g; g/4.25g; g/4.25g
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 54473-292-01

4.25 g in 1 APPLICATOR (54473-292-01)
Marketing Start Date2018-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54473-292-01 [54473029201]

Sun Shades Lip Balm Mango Lime STICK
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-01-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
AVOBENZONE.1175 g/4.25g

OpenFDA Data

SPL SET ID:68802872-fbd9-6763-e053-2991aa0a7383
Manufacturer
UNII

NDC Crossover Matching brand name "Sun Shades Lip Balm Mango Lime" or generic name "Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 3%"

NDCBrand NameGeneric Name
54473-214Sun Shades Lip BalmAvobenzone 2.5%, Octinoxate 6%, Oxybenzone 3%
54473-215Sun Shades Lip BalmAvobenzone 2.5%, Octinoxate 6%, Oxybenzone 3%
54473-217Sun Shades Lip BalmAvobenzone 2.5%, Octinoxate 6%, Oxybenzone 3%
54473-219Sun Shades Lip BalmAvobenzone 2.5%, Octinoxate 6%, Oxybenzone 3%
54473-220Sun Shades Lip BalmAvobenzone 2.5%, Octinoxate 6%, Oxybenzone 3%
54473-226Sun Shades Lip BalmAvobenzone 2.5%, Octinoxate 6%, Oxybenzone 3%
54473-244Sun Shades Lip BalmAvobenzone 2.5%, Octinoxate 6%, Oxybenzone 3%
54473-245Sun Shades Lip BalmAvobenzone 2.5%, Octinoxate 6%, Oxybenzone 3%
54473-246Sun Shades Lip BalmAvobenzone 2.5%, Octinoxate 6%, Oxybenzone 3%
54473-254Sun Shades Lip BalmAvobenzone 2.5%, Octinoxate 6%, Oxybenzone 3%
54473-255Sun Shades Lip BalmAvobenzone 2.5%, Octinoxate 6%, Oxybenzone 3%
54473-257Sun Shades Lip BalmAvobenzone 2.5%, Octinoxate 6%, Oxybenzone 3%
54473-292Sun Shades Lip BalmAvobenzone 2.5%, Octinoxate 6%, Oxybenzone 3%

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