NDC 53675-171

Broad Spectrum Water Resistant SPF 50 Mineral Sunscreen

Titanium Dioxide, Zinc Oxide

Broad Spectrum Water Resistant SPF 50 Mineral Sunscreen is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Aruba Aloe Balm Nv. The primary component is Titanium Dioxide; Zinc Oxide.

Product ID53675-171_5c77bc11-1806-3f1a-e053-2a91aa0a857d
NDC53675-171
Product TypeHuman Otc Drug
Proprietary NameBroad Spectrum Water Resistant SPF 50 Mineral Sunscreen
Generic NameTitanium Dioxide, Zinc Oxide
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2017-10-25
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart352
Labeler NameAruba Aloe Balm NV
Substance NameTITANIUM DIOXIDE; ZINC OXIDE
Active Ingredient Strength100 mg/mL; mg/mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 53675-171-00

59 mL in 1 TUBE (53675-171-00)
Marketing Start Date2017-10-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53675-171-00 [53675017100]

Broad Spectrum Water Resistant SPF 50 Mineral Sunscreen CREAM
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-10-25

Drug Details

Active Ingredients

IngredientStrength
TITANIUM DIOXIDE100 mg/mL

OpenFDA Data

SPL SET ID:dafde944-2b06-4a94-8266-24622b680684
Manufacturer
UNII
UPC Code
  • 0082252071304
  • NDC Crossover Matching brand name "Broad Spectrum Water Resistant SPF 50 Mineral Sunscreen" or generic name "Titanium Dioxide, Zinc Oxide"

    NDCBrand NameGeneric Name
    53675-171Broad Spectrum Water Resistant SPF 50 Mineral SunscreenBroad Spectrum Water Resistant SPF 50 Mineral Sunscreen
    10477-1003All Physical Sunscreen Broad Spectrum SPF 50Titanium Dioxide, Zinc Oxide
    0311-0710ALMAY SMART SHADE ANTI-AGING SKINTONE MATCHING MAKEUP SPF 20Titanium Dioxide, Zinc Oxide
    10096-0241Anew Solar AdvanceTITANIUM DIOXIDE, ZINC OXIDE
    10096-0260AvonTitanium Dioxide, Zinc Oxide
    0316-2056Blue Lizard Sensitive Face SunscreenTitanium Dioxide, Zinc Oxide
    0316-2064Blue Lizard Sheer SPF 50 SunscreenTitanium Dioxide, Zinc Oxide
    0187-2204CeraVeTitanium Dioxide, Zinc Oxide
    0187-2205CeraVeTitanium Dioxide, Zinc Oxide
    0187-2208CeraVeTitanium Dioxide, Zinc Oxide
    0187-2209CeraVeTitanium Dioxide, Zinc Oxide
    0187-2210CeraVeTitanium Dioxide, Zinc Oxide
    0299-5889Cetaphil Redness Relieving Daily Facial Moisturizer with sunscreen SPF 20titanium dioxide, zinc oxide
    0299-4111Cetaphil Sheer Mineral Sunscreen SPF 30titanium dioxide, zinc oxide
    0299-4112Cetaphil Sheer Mineral Sunscreen SPF 50titanium dioxide, zinc oxide
    0299-4122Cetaphil Sheer Mineral Sunscreen SPF 50titanium dioxide, zinc oxide
    0299-4108Cetaphil Sheer Mineral Sunscreen Stick SPF 50titanium dioxide, zinc oxide
    11090-114ITC Bye Bye Foundation Full Coverage Moisturizer FairTitanium Dioxide, Zinc Oxide
    11090-115ITC Bye Bye Foundation Full Coverage Moisturizer Fair LightTitanium Dioxide, Zinc Oxide
    11090-103ITC CC Full Coverage Cream FairTitanium Dioxide, Zinc Oxide
    11090-104ITC CC Full Coverage Cream Fair LightTitanium Dioxide, Zinc Oxide
    11090-105ITC CC Full Coverage Cream LightTitanium Dioxide, Zinc Oxide
    11090-106ITC CC Full Coverage Cream Light MediumTitanium Dioxide, Zinc Oxide
    11090-107ITC CC Full Coverage Cream MediumTitanium Dioxide, Zinc Oxide
    11090-109ITC CC Full Coverage Cream Medium TanTitanium Dioxide, Zinc Oxide
    11090-108ITC CC Full Coverage Cream Neutral MediumTitanium Dioxide, Zinc Oxide
    11090-110ITC CC Full Coverage Cream Neutral TanTitanium Dioxide, Zinc Oxide
    11090-112ITC CC Full Coverage Cream RichTitanium Dioxide, Zinc Oxide
    11090-113ITC CC Full Coverage Cream Rich HoneyTitanium Dioxide, Zinc Oxide
    11090-111ITC CC Full Coverage Cream TanTitanium Dioxide, Zinc Oxide
    0363-3560OLOGYTITANIUM DIOXIDE, ZINC OXIDE
    10967-670PREVAGE CITY SMARTTITANIUM DIOXIDE, ZINC OXIDE
    10967-631REVLON PHOTOREADY INSTA-FIX MAKEUPtitanium dioxide, zinc oxide
    0363-0962WALGREENS KIDS BABY SPF 50Titanium Dioxide, Zinc oxide

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