NDC 76354-107

SPF-45 SUNSCREEN

Titanium Dioxide, Zinc Oxide

SPF-45 SUNSCREEN is a Topical Powder in the Human Otc Drug category. It is labeled and distributed by J. A. Cosmetics U.s. Inc. The primary component is Titanium Dioxide; Zinc Oxide.

Product ID76354-107_1629814c-6550-4ec0-b4b1-5ef80843dcfa
NDC76354-107
Product TypeHuman Otc Drug
Proprietary NameSPF-45 SUNSCREEN
Generic NameTitanium Dioxide, Zinc Oxide
Dosage FormPowder
Route of AdministrationTOPICAL
Marketing Start Date2014-05-12
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart352
Labeler NameJ. A. Cosmetics U.S. INC
Substance NameTITANIUM DIOXIDE; ZINC OXIDE
Active Ingredient Strength23 g/100g; 1/100g
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 76354-107-51

1 CONTAINER in 1 BOX (76354-107-51) > 10 g in 1 CONTAINER (76354-107-31)
Marketing Start Date2014-05-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 76354-107-31 [76354010731]

SPF-45 SUNSCREEN POWDER
Marketing CategoryOTC monograph final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-05-12
Marketing End Date2017-12-31

NDC 76354-107-51 [76354010751]

SPF-45 SUNSCREEN POWDER
Marketing CategoryOTC monograph final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-05-12
Marketing End Date2017-12-31
Inactivation Date2019-11-27
Reactivation Date2019-12-26

Drug Details

Active Ingredients

IngredientStrength
TITANIUM DIOXIDE23.3 g/100g

OpenFDA Data

SPL SET ID:eaf3f9ce-c9f6-4aba-80d9-457b13e57202
Manufacturer
UNII

NDC Crossover Matching brand name "SPF-45 SUNSCREEN" or generic name "Titanium Dioxide, Zinc Oxide"

NDCBrand NameGeneric Name
76354-107SPF-45 SUNSCREENSPF-45 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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