Havana Sun SPF 30 Sunscreen by Derma Care Research Labs, LLC

Havana Sun SPF 30 Sunscreen by

Drug Labeling and Warnings

Havana Sun SPF 30 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Derma Care Research Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAVANA SUN SPF 30 SUNSCREEN- avobenzone 3%, homosalate 15%, octisalate 5%, octocrylene 6% 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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Active Ingredients

Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 6%

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:

  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours

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:

  • limit time in the sun, especially from 10 am to 2 pm
  • wear long-sleeved shirts, pants, hats, and sunglasses.
  • Children under 6 months: ask a doctor.

Inactive Ingredients

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

Label

LabelLabel

HAVANA SUN SPF 30 SUNSCREEN 
avobenzone 3%, homosalate 15%, octisalate 5%, octocrylene 6% lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 72839-081
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE15 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE6 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
EICOSYL POVIDONE (UNII: XQQ9MKE2BJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
DIMETHICONE 20 (UNII: H8YMB5QY0D)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
TOCOPHEROL (UNII: R0ZB2556P8)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 72839-081-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/29/202111/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/29/202111/01/2021
Labeler - Derma Care Research Labs, LLC (116817470)

Revised: 1/2023
Document Id: f2a09b58-e0ae-b4f8-e053-2995a90a9bf2
Set id: c120f035-9169-23e5-e053-2995a90a7b88
Version: 2
Effective Time: 20230119