NDC 53798-020

SKYLAKE SUNSCREEN

Octinoxate, Zinc Oxide, Titanium Dioxide

SKYLAKE SUNSCREEN is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Skylake. The primary component is Octinoxate; Zinc Oxide; Titanium Dioxide.

Product ID53798-020_c40e005b-c52c-40ea-9a30-233bef66d142
NDC53798-020
Product TypeHuman Otc Drug
Proprietary NameSKYLAKE SUNSCREEN
Generic NameOctinoxate, Zinc Oxide, Titanium Dioxide
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2019-03-01
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart352
Labeler NameSKYLAKE
Substance NameOCTINOXATE; ZINC OXIDE; TITANIUM DIOXIDE
Active Ingredient Strength4 g/50g; g/50g; g/50g
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 53798-020-02

1 CONTAINER in 1 CARTON (53798-020-02) > 50 g in 1 CONTAINER (53798-020-01)
Marketing Start Date2019-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53798-020-02 [53798002002]

SKYLAKE SUNSCREEN CREAM
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-03-01

NDC 53798-020-01 [53798002001]

SKYLAKE SUNSCREEN CREAM
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-03-01

Drug Details

Active Ingredients

IngredientStrength
OCTINOXATE3.75 g/50g

OpenFDA Data

SPL SET ID:1d1fbc7e-e4a7-449e-99ec-af209fc9bcf4
Manufacturer
UNII
UPC Code
  • 8809124633055

    • NDC Crossover Matching brand name "SKYLAKE SUNSCREEN" or generic name "Octinoxate, Zinc Oxide, Titanium Dioxide"

    NDCBrand NameGeneric Name
    53798-020SKYLAKE SUNSCREENOctinoxate, Zinc Oxide, Titanium Dioxide
    43526-122COLOR CORRECTING PRIMER GREENOCTINOXATE, ZINC OXIDE, TITANIUM DIOXIDE
    43526-123COLOR CORRECTING PRIMER PURPLEOCTINOXATE, ZINC OXIDE, TITANIUM DIOXIDE
    49527-712EVEN BETTER MAKEUPOCTINOXATE, ZINC OXIDE, TITANIUM DIOXIDE
    13733-412Limited Line Edition 2018 MISSHA M Perfect Cover BB No 21Octinoxate, Zinc Oxide, Titanium Dioxide
    13733-411Limited Line Edition 2018 MISSHA M Perfect Cover BB No 23Octinoxate, Zinc Oxide, Titanium Dioxide
    70117-001MAKEUP SUN PRIMEROCTINOXATE, ZINC OXIDE, TITANIUM DIOXIDE
    13733-219MISSHA M Perfect Cover BB SPF42 No21Octinoxate, Zinc Oxide, Titanium Dioxide
    13733-220MISSHA M Perfect Cover BB SPF42 No23Octinoxate, Zinc Oxide, Titanium Dioxide
    13733-245MISSHA M Perfect Cover BB SPF42 No29Octinoxate, Zinc Oxide, Titanium Dioxide
    53208-437OHUI Sun Science Powder Sun Block Natural SkinOCTINOXATE, Zinc Oxide, Titanium Dioxide
    51346-523PROVENCE AIR SKIN FIT ONE DAY LASTING FOUNDATION N45 TAN BROWNOCTINOXATE, ZINC OXIDE, TITANIUM DIOXIDE
    51346-464PROVENCE INTENSIVE AMPOULE MAKE UP BASE 01 MINTOctinoxate, Zinc Oxide, Titanium Dioxide
    51346-420PROVENCE INTENSIVE AMPOULE MAKE UP BASE 02 LAVENDEROctinoxate, Zinc Oxide, Titanium Dioxide
    51346-204PROVENCE MAKEUP BASEOCTINOXATE, Zinc Oxide, Titanium Dioxide
    51346-205PROVENCE MAKEUP BASEOCTINOXATE, Zinc Oxide, Titanium Dioxide
    51346-020RED GINSENG FERMENTED SUNOCTINOXATE, ZINC OXIDE, TITANIUM DIOXIDE
    62242-010SUPREME SKINPIA 10 SUN BLOCKOctinoxate, Zinc Oxide, Titanium Dioxide
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