NDC 71597-060

ACWELL UV CUT Waterproof Sun

Zinc Oxide, Homosalate, Octisalate, Titanium Dioxide

ACWELL UV CUT Waterproof Sun is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Bnhcosmetics Co.,ltd.. The primary component is Zinc Oxide; Homosalate; Octisalate; Titanium Dioxide.

Product ID71597-060_7b0b5f71-f053-4727-97ae-8cb7c69cefe8
NDC71597-060
Product TypeHuman Otc Drug
Proprietary NameACWELL UV CUT Waterproof Sun
Generic NameZinc Oxide, Homosalate, Octisalate, Titanium Dioxide
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2019-08-01
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart352
Labeler NameBNHCOSMETICS CO.,LTD.
Substance NameZINC OXIDE; HOMOSALATE; OCTISALATE; TITANIUM DIOXIDE
Active Ingredient Strength5 g/50g; g/50g; g/50g; g/50g
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 71597-060-02

1 CONTAINER in 1 CARTON (71597-060-02) > 50 g in 1 CONTAINER (71597-060-01)
Marketing Start Date2019-08-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71597-060-01 [71597006001]

ACWELL UV CUT Waterproof Sun CREAM
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-08-01

NDC 71597-060-02 [71597006002]

ACWELL UV CUT Waterproof Sun CREAM
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-08-01

Drug Details

Active Ingredients

IngredientStrength
ZINC OXIDE4.65 g/50g

OpenFDA Data

SPL SET ID:b0596dcb-6347-4db3-831d-251f6c69f884
Manufacturer
UNII
UPC Code
  • 8809129644001
  • NDC Crossover Matching brand name "ACWELL UV CUT Waterproof Sun" or generic name "Zinc Oxide, Homosalate, Octisalate, Titanium Dioxide"

    NDCBrand NameGeneric Name
    71597-060ACWELL UV CUT Waterproof SunZINC OXIDE, HOMOSALATE, OCTISALATE, TITANIUM DIOXIDE
    52554-1200Cell Fusion C Laser SunscreenZINC OXIDE, HOMOSALATE, OCTISALATE, TITANIUM DIOXIDE
    70976-007KLAVUU UV Protection Secret Tone Up SunscreenZinc Oxide, Homosalate, Octisalate, Titanium Dioxide

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