NDC 76138-218

5414 Sunscreen

Avobenzone, Homosalate, Octocrylene, Octisalate

5414 Sunscreen is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Innovation Specialties. The primary component is Avobenzone; Homosalate; Octisalate; Octocrylene.

Product ID76138-218_1d77fcd3-8a06-4e8e-8dba-a58b99cb9d14
NDC76138-218
Product TypeHuman Otc Drug
Proprietary Name5414 Sunscreen
Generic NameAvobenzone, Homosalate, Octocrylene, Octisalate
Dosage FormLotion
Route of AdministrationTOPICAL
Marketing Start Date2018-12-20
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart352
Labeler NameInnovation Specialties
Substance NameAVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active Ingredient Strength3 g/100mL; g/100mL; g/100mL; g/100mL
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 76138-218-01

30 mL in 1 BOTTLE, PLASTIC (76138-218-01)
Marketing Start Date2018-12-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 76138-218-01 [76138021801]

5414 Sunscreen LOTION
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-12-20

Drug Details

Active Ingredients

IngredientStrength
AVOBENZONE3 g/100mL

OpenFDA Data

SPL SET ID:baac8e11-cd39-46e6-b013-3d3490512c5e
Manufacturer
UNII

NDC Crossover Matching brand name "5414 Sunscreen" or generic name "Avobenzone, Homosalate, Octocrylene, Octisalate"

NDCBrand NameGeneric Name
76138-2185414 SunscreenAvobenzone, Homosalate, Octocrylene, Octisalate
76138-2195281 SUNSCREENAvobenzone, Homosalate, Octocrylene, Octisalate
76138-2205298 SUNSCREENAvobenzone, Homosalate, Octocrylene, Octisalate
76138-2215299 SUNSCREENAvobenzone, Homosalate, Octocrylene, Octisalate
76261-127Hydrating Lip Balm SPF 15 sunscreenAvobenzone, Homosalate, Octocrylene, Octisalate
14222-2252REDEFINE Triple DefenseAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE
14222-2300REVERSE Brightening Defense FluidAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE
70412-816SPF 15 Lip and SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE
79021-010SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE
70412-316SPF15AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE
70412-212SPF15 SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE
70412-211SPF30 SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE
70412-818SPF30 Sunscreen and SPF15AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE
61995-2020Sport Sunscreen SPF 45Avobenzone, Homosalate, Octocrylene, Octisalate
69039-604Sun Bum Sunscreen Lip Balm Broad Spectrum SPF 30 BananaAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE
69039-602Sun Bum Sunscreen Lip Balm Broad Spectrum SPF 30 CoconutAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE
69039-607Sun Bum Sunscreen Lip Balm Broad Spectrum SPF 30 KeylimeAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE
69039-606Sun Bum Sunscreen Lip Balm Broad Spectrum SPF 30 MangoAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE
69039-605Sun Bum Sunscreen Lip Balm Broad Spectrum SPF 30 PineappleAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE
69039-603Sun Bum Sunscreen Lip Balm Broad Spectrum SPF 30 PomegranateAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE
69039-601Sun Bum Sunscreen Lip Balm Broad Spectrum SPF 30 WatermelonAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE
82953-003sunscreenavobenzone, homosalate, octocrylene, octisalate
80524-002Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE
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