NDC 52854-046

Reef Safe SPF 45

Homosalate, Octocrylene, Octinoxate, Oxybenzone And Octisalate

Reef Safe SPF 45 is a Topical Spray in the Human Otc Drug category. It is labeled and distributed by Tropical Seas, Inc.. The primary component is Homosalate; Octocrylene; Octinoxate; Oxybenzone; Octisalate.

Product ID52854-046_880c7abd-d9f7-46bf-9fcf-87d06c71897c
NDC52854-046
Product TypeHuman Otc Drug
Proprietary NameReef Safe SPF 45
Generic NameHomosalate, Octocrylene, Octinoxate, Oxybenzone And Octisalate
Dosage FormSpray
Route of AdministrationTOPICAL
Marketing Start Date2013-01-01
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart352
Labeler NameTropical Seas, Inc.
Substance NameHOMOSALATE; OCTOCRYLENE; OCTINOXATE; OXYBENZONE; OCTISALATE
Active Ingredient Strength10 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 52854-046-01

250 mL in 1 BOTTLE, PLASTIC (52854-046-01)
Marketing Start Date2013-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52854-046-01 [52854004601]

Reef Safe SPF 45 SPRAY
Marketing CategoryOTC monograph not final
Application Numberpart352
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-01-01

Drug Details

Active Ingredients

IngredientStrength
HOMOSALATE10 g/100mL

OpenFDA Data

SPL SET ID:b3f5b5f1-c238-49c9-8683-f931afae0c1b
Manufacturer
UNII

NDC Crossover Matching brand name "Reef Safe SPF 45" or generic name "Homosalate, Octocrylene, Octinoxate, Oxybenzone And Octisalate"

NDCBrand NameGeneric Name
52854-045Reef Safe SPF 45octocrylene, octinoxate, oxybenzone, homosalate and octisalate
52854-046Reef Safe SPF 45homosalate, octocrylene, octinoxate, oxybenzone and octisalate
52854-031Reef Safe SPF 30homosalate, octocrylene, octinoxate, oxybenzone and octisalate

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