NDC 36800-870

Baby Gentle Sunscreen SPF 50

Avobenzone - 3.0% Homosalate - 13.0% Octisalate - 5.0% Octocrylene - 7.0% Oxybenzone 4%

Baby Gentle Sunscreen SPF 50 is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Topco. The primary component is Avobenzone; Homosalate; Octisalate; Octocrylene; Oxybenzone.

Product ID36800-870_3bd2fe9a-0748-43ea-b372-72b52a398512
NDC36800-870
Product TypeHuman Otc Drug
Proprietary NameBaby Gentle Sunscreen SPF 50
Generic NameAvobenzone - 3.0% Homosalate - 13.0% Octisalate - 5.0% Octocrylene - 7.0% Oxybenzone 4%
Dosage FormLotion
Route of AdministrationTOPICAL
Marketing Start Date2016-04-21
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart352
Labeler NameTopCo
Substance NameAVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Active Ingredient Strength3 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 36800-870-06

237 mL in 1 BOTTLE (36800-870-06)
Marketing Start Date2016-04-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36800-870-06 [36800087006]

Baby Gentle Sunscreen SPF 50 LOTION
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-04-21
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
AVOBENZONE3 g/100mL

OpenFDA Data

SPL SET ID:94a11f26-2de6-446f-8122-d82b2d64f5ee
Manufacturer
UNII

NDC Crossover Matching brand name "Baby Gentle Sunscreen SPF 50" or generic name "Avobenzone - 3.0% Homosalate - 13.0% Octisalate - 5.0% Octocrylene - 7.0% Oxybenzone 4%"

NDCBrand NameGeneric Name
36800-870Baby Gentle Sunscreen SPF 50Avobenzone - 3.0% Homosalate - 13.0% Octisalate - 5.0% Octocrylene - 7.0% Oxybenzone 4%
11822-7789Baby Sunscreen SPF 50Avobenzone - 3.0% Homosalate - 13.0% Octisalate - 5.0% Octocrylene - 7.0% Oxybenzone 4%
41520-364Baby Sunscreen SPF 50Avobenzone - 3.0% Homosalate - 13.0% Octisalate - 5.0% Octocrylene - 7.0% Oxybenzone 4%

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