NDC 76138-205

5283 sunscreen

Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide

5283 sunscreen is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Innovation Specialties. The primary component is Octinoxate; Octisalate; Oxybenzone; Titanium Dioxide.

Product ID76138-205_e940dc34-f5e5-472d-903f-0580ebe47165
NDC76138-205
Product TypeHuman Otc Drug
Proprietary Name5283 sunscreen
Generic NameOctinoxate, Octisalate, Oxybenzone, Titanium Dioxide
Dosage FormLotion
Route of AdministrationTOPICAL
Marketing Start Date2017-05-15
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart352
Labeler NameInnovation Specialties
Substance NameOCTINOXATE; OCTISALATE; OXYBENZONE; TITANIUM DIOXIDE
Active Ingredient Strength8 g/100mL; g/100mL; g/100mL; g/100mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 76138-205-01

30 mL in 1 BOTTLE, PLASTIC (76138-205-01)
Marketing Start Date2017-05-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 76138-205-01 [76138020501]

5283 sunscreen LOTION
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-05-15
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
OCTINOXATE7.5 g/100mL

OpenFDA Data

SPL SET ID:2cd546eb-33a8-4be5-97e0-bd3ff07cf87f
Manufacturer
UNII

NDC Crossover Matching brand name "5283 sunscreen" or generic name "Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide"

NDCBrand NameGeneric Name
76138-2055283 sunscreenOctinoxate, Octisalate, Oxybenzone, Titanium dioxide
76138-2165283 sunscreenOctocrylene, Titanium dioxide, Octisalate
76138-2075281 sunscreenOctinoxate, Octisalate, Oxybenzone, Titanium dioxide
76138-2065298 sunscreenOctinoxate, Octisalate, Oxybenzone, Titanium Dioxide
76209-234De-Aging Moisturizing Day Creme With Sunscreen SPF 20OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE
50184-1062miracle worker anti-aging foundation spf 30Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide
65435-0133Safe Sea For Kids Sunscreen With Jellyfish Sting Protective SPF 30 PlusOCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE
65435-0131Safe Sea Sunscreen With Jellyfish Sting Protective SPF 30OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE
50184-4700Shelter Tintedoctinoxate, octisalate, oxybenzone, titanium dioxide
31190-320SPF 30 SUNSCREENOCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE
31190-330SPF 30 SUNSCREENOCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE
71160-011SPF 30 SunscreenOCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE
71160-012SPF 30 SunscreenOCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE
71160-013SPF 30 SunscreenOCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE
71160-014SPF 30 SUNSCREENOCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE
71160-010SPF 30 Sunscreen with SoybeanOCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE
70392-013SPF 50 Stay Put SunscreenOCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE
70392-014SPF 50 Stay Put SunscreenOCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE
70392-015SPF 50 Stay Put SunscreenOCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE
70445-159SSLT2 Sun ScreenOctinoxate, Octisalate, Oxybenzone, Titanium Dioxide
70445-156Sun ScreenOctinoxate, Octisalate, Oxybenzone, Titanium Dioxide
70445-157Sun ScreenOctinoxate, Octisalate, Oxybenzone, Titanium Dioxide
70445-158Sun ScreenOctinoxate, Octisalate, Oxybenzone, Titanium Dioxide
52675-030SunScreenOctinoxate, Octisalate, Oxybenzone, Titanium Dioxide
70412-230SunscreenOCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE
70412-239SunscreenOCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE
31190-210Sunscreen SPF 30Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide
31190-500SunScreen SPF30OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE
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