CARIBBEAN BREEZE SPF 30 SUNSCREEN- avobenzone 3%, homosalate 15%, octisalate 5%, octocrylene 8% spray 
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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Caribbean Breeze SPF 30 CS

Active Ingredients

Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 8%

Purpose

Sunscreen

Uses

Warnings

For external use only. Flammable: do not use while smoking or near heat or flame.

Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse eyes with water to remove. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120 degrees F.

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:

Hold container 4 to 6 inches from the skin to apply. Do not spray directly into face. Spray on hands then apply to face. Do no apply in windy conditions. Use in a well-ventilated area.

Inactive Ingredients

Acrylates/Octylacrylamide Copolymer, Alcohol Denat., Caprylic/Capric Triglyceride, Diethylhexyl Syringylidenemalonate, Fragrance, Glycerin, Tocopherol.

Label

Label

CARIBBEAN BREEZE SPF 30 SUNSCREEN 
avobenzone 3%, homosalate 15%, octisalate 5%, octocrylene 8% spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72839-289
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE15 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE8 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
GLYCERIN (UNII: PDC6A3C0OX)  
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72839-289-05156 g in 1 CAN; Type 0: Not a Combination Product12/12/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/12/2022
Labeler - Derma Care Research Labs, LLC (116817470)
Registrant - Derma Care Research Labs, LLC (116817470)

Revised: 4/2023
Document Id: f8730f9c-43c2-f4d3-e053-6294a90a1809
Set id: f8730f9c-43c1-f4d3-e053-6294a90a1809
Version: 1
Effective Time: 20230403
 
Derma Care Research Labs, LLC