NDC 63550-851

SUN DEFENSE SPF 30

Avobenzone Octinoxate Oxybenzone Titanium Dioxide

SUN DEFENSE SPF 30 is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Kamins Dermatologics Inc.. The primary component is Avobenzone; Octinoxate; Oxybenzone; Titanium Dioxide.

Product ID63550-851_bb4d7be9-2550-424b-80a0-b968df95e619
NDC63550-851
Product TypeHuman Otc Drug
Proprietary NameSUN DEFENSE SPF 30
Generic NameAvobenzone Octinoxate Oxybenzone Titanium Dioxide
Dosage FormLotion
Route of AdministrationTOPICAL
Marketing Start Date2011-09-02
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart352
Labeler NameKamins Dermatologics Inc.
Substance NameAVOBENZONE; OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE
Active Ingredient Strength25 mg/mL; mg/mL; mg/mL; mg/mL
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 63550-851-10

120 mL in 1 BOX (63550-851-10)
Marketing Start Date2011-09-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63550-851-10 [63550085110]

SUN DEFENSE SPF 30 LOTION
Marketing CategoryOTC monograph final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-09-02
Inactivation Date2019-10-29

Drug Details

Active Ingredients

IngredientStrength
AVOBENZONE25 mg/mL

OpenFDA Data

SPL SET ID:018fd6aa-fa5c-4ebf-95ce-f43d3fcaccc8
Manufacturer
UNII

NDC Crossover Matching brand name "SUN DEFENSE SPF 30" or generic name "Avobenzone Octinoxate Oxybenzone Titanium Dioxide"

NDCBrand NameGeneric Name
63550-851SUN DEFENSE SPF 30Avobenzone Octinoxate Oxybenzone Titanium dioxide
63550-811SUNBAR SPF 30Avobenzone Octinoxate Oxybenzone Titanium dioxide

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