NDC 53675-180

Broad Spectrum SPF 30 Water Resistant (80 Minutes)

Titanium Dioxide, Zinc Oxide

Broad Spectrum SPF 30 Water Resistant (80 Minutes) 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 ID53675-180_70cb5532-bf4f-d9bf-e053-2a91aa0acb1f
NDC53675-180
Product TypeHuman Otc Drug
Proprietary NameBroad Spectrum SPF 30 Water Resistant (80 Minutes)
Generic NameTitanium Dioxide, Zinc Oxide
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2018-09-01
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 53675-180-00

177 mL in 1 TUBE (53675-180-00)
Marketing Start Date2018-09-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53675-180-00 [53675018000]

Broad Spectrum SPF 30 Water Resistant (80 Minutes) CREAM
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-09-01

Drug Details

Active Ingredients

IngredientStrength
TITANIUM DIOXIDE100 mg/mL

OpenFDA Data

SPL SET ID:20830b77-b37b-4cea-8786-bd379bbfeeb3
Manufacturer
UNII
UPC Code
  • 0082252071403
  • NDC Crossover Matching brand name "Broad Spectrum SPF 30 Water Resistant (80 Minutes)" or generic name "Titanium Dioxide, Zinc Oxide"

    NDCBrand NameGeneric Name
    53675-180Broad Spectrum SPF 30 Water Resistant (80 Minutes)Broad Spectrum SPF 30 Water Resistant (80 Minutes)
    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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