HABANA BRISA SPF 70 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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Habana Brisa SPF 70 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, C12-15 Alkyl Benzoate, Carbomer, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Fragrance, Phenoxyethanol, Polyglyceryl-3 Methylglucose Distearate, Sorbitan Isostearate, Sorbitol, Stearic Acid, Tocopherol, Triethanolamine, VP/Eicosene Copolymer, Water

Label

LabelLabel

HABANA BRISA SPF 70 SUNSCREEN 
avobenzone 3%, homosalate 15%, octisalate 5%, octocrylene 10% lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72839-193
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE15 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
TROLAMINE (UNII: 9O3K93S3TK)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
EICOSYL POVIDONE (UNII: XQQ9MKE2BJ)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
TOCOPHEROL (UNII: R0ZB2556P8)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE (UNII: W19EIO0DBE)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
SORBITOL (UNII: 506T60A25R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
WATER (UNII: 059QF0KO0R)  
DIMETHICONE 350 (UNII: 2Y53S6ATLU)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72839-193-08227 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/31/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/31/2022
Labeler - Derma Care Research Labs, LLC (116817470)
Registrant - Derma Care Research Labs, LLC (116817470)
Establishment
NameAddressID/FEIBusiness Operations
Derma Care Research Labs116817470manufacture(72839-193)

Revised: 3/2022
Document Id: dafc5532-a7bd-5558-e053-2995a90aec68
Set id: dafc5532-a7bc-5558-e053-2995a90aec68
Version: 1
Effective Time: 20220324
 
Derma Care Research Labs, LLC