NDC 54473-226

Sun Shades Lip Balm Pina Colada

Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 3%

Sun Shades Lip Balm Pina Colada 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 ID54473-226_687f4857-e46e-4dff-e053-2a91aa0aa4ad
NDC54473-226
Product TypeHuman Otc Drug
Proprietary NameSun Shades Lip Balm Pina Colada
Generic NameAvobenzone 2.5%, Octinoxate 6%, Oxybenzone 3%
Dosage FormStick
Route of AdministrationTOPICAL
Marketing Start Date2013-02-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH 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 54473-226-04

4.25 g in 1 TUBE (54473-226-04)
Marketing Start Date2018-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54473-226-01 [54473022601]

Sun Shades Lip Balm Pina Colada STICK
Marketing CategoryOTC monograph final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-02-01
Marketing End Date2018-03-28

NDC 54473-226-04 [54473022604]

Sun Shades Lip Balm Pina Colada STICK
Marketing CategoryOTC monograph final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-01-01
Inactivation Date2020-01-31
Reactivation Date2020-03-19

Drug Details

Active Ingredients

IngredientStrength
AVOBENZONE.1175 g/4.25g

OpenFDA Data

SPL SET ID:16d0d2d2-b9c4-4491-8d8a-815843d342e8
Manufacturer
UNII

NDC Crossover Matching brand name "Sun Shades Lip Balm Pina Colada" 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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