NDC 54473-218

Sun Shades Mineral Plus Sunscreen with Zinc Oxide

Octisalate 5%, Octocrylene 3%, Zinc Oxide 10.5%

Sun Shades Mineral Plus Sunscreen with Zinc Oxide is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Melaleuca Inc.. The primary component is Octisalate; Octocrylene; Zinc Oxide.

Product ID54473-218_68803a2e-9bdc-107d-e053-2a91aa0a5ce4
NDC54473-218
Product TypeHuman Otc Drug
Proprietary NameSun Shades Mineral Plus Sunscreen with Zinc Oxide
Generic NameOctisalate 5%, Octocrylene 3%, Zinc Oxide 10.5%
Dosage FormLotion
Route of AdministrationTOPICAL
Marketing Start Date2012-12-27
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart352
Labeler NameMelaleuca Inc.
Substance NameOCTISALATE; OCTOCRYLENE; ZINC OXIDE
Active Ingredient Strength9 g/177mL; g/177mL; g/177mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 54473-218-06

177 mL in 1 TUBE (54473-218-06)
Marketing Start Date2018-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54473-218-06 [54473021806]

Sun Shades Mineral Plus Sunscreen with Zinc Oxide LOTION
Marketing CategoryOTC monograph not 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
OCTISALATE9.225 g/177mL

OpenFDA Data

SPL SET ID:8886cbd0-ed2b-4a2b-a724-a0d4f12296c9
Manufacturer
UNII

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