FRESH COAST SPF 50 SUNSCREEN- avobenzone 3%, homosalate 15%, octisalate 5%, octocrylene 10% lotion 
Derma Care Research Labs, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Fresh Coast SPF 50 Sunscreen Lotion

Active Ingredients

Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%

Purpose

Sunscreen

Uses

Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only.

Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse eyes with water to remove.

Stop use and ask a doctor if rash occurs.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply liberally 15 minutes before sun exposure. Reapply:

Sun protection measures: spending time n the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measure including:

Inactive Ingredients

Aluminum Starch Octenylsuccinate, Benzyl Alcohol, Carbomer, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Fragrance, Phenoxyethanol, Polyglyceryl-3 Methylglucose Distearate, Sorbitan Isostearate, Sorbitol, Stearic Acid, Tocopherol, Triethanolamine, VP/Eicosene Copolymer, Water

Label

Label

FRESH COAST SPF 50 SUNSCREEN 
avobenzone 3%, homosalate 15%, octisalate 5%, octocrylene 10% lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72839-135
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE15 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER 940 (UNII: 4Q93RCW27E)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
DIMETHICONE 200 (UNII: RGS4T2AS00)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE (UNII: W19EIO0DBE)  
TROLAMINE (UNII: 9O3K93S3TK)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
EICOSYL POVIDONE (UNII: XQQ9MKE2BJ)  
SORBITOL (UNII: 506T60A25R)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
WATER (UNII: 059QF0KO0R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72839-135-05142 g in 1 TUBE; Type 0: Not a Combination Product05/26/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/26/2022
Labeler - Derma Care Research Labs, LLC (116817470)
Registrant - Derma Care Research Labs, LLC (116817470)
Establishment
NameAddressID/FEIBusiness Operations
Derma Care Research Labs116817470manufacture(72839-135)

Revised: 8/2023
Document Id: 043cadde-ba08-7c77-e063-6394a90abee6
Set id: 043cadde-ba07-7c77-e063-6394a90abee6
Version: 1
Effective Time: 20230831
 
Derma Care Research Labs, LLC