BEACH BREAK 2-IN-1 DAILY FACIAL MOISTURIZER SUNSCREEN SPF 30- homosalate, octisalate, avobenzone, octocrylene lotion 
EAI-JR 286

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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Beach Break 2-in-1 Daily Facial Moisturizer Sunscreen SPF 30

Active Ingredients Purpose

Homosalate 8% Sunscreen

Octisalate 5%

Avobenzone 3%

Octocrylene 2%

Uses

Keep out of reach of children

Stop use and ask a doctor if rash occurs

Warnings

Directions

Apply liberally 15 minutes before sun exposure and at least every 2 hours

Reapply:

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF of 15 or higher and other sun protection measures including:

Inactive Ingredients

Water (Aqua), Diisopropyl Adidpate, Dicaprylyl Ether, Pentylene Glycol, Stearyl/octyldodecyl Citrate Crosspolymer, Glycerin, Cetyl Alcohol, Potassium Cetyl Phosphate, Phenoxyethanol, Glyceryl Caprylate, Sodium Polyacrylate, Cetearyl Olivate, Sorbitan Olivate, Ferulic Acid, Tetrahexyldecyl Ascorbate, Caprylic/Capric Triglyceride, Limonene, Caprylhydroxamic Acid, Citrus Aurantium Dulcis (Orange) Peel Oil, Ethylhexylglycerin, Niacinamide, Sodium Gluconate, Aminomethyl Propanol, Citrus Aurantium Bergamia (Bergamot) Peel Oil, Jasminum Officinale (Jasmine) Extract, Linalool, Tocopherol, Eugenia Caryophyllus (Clove) Flower Extract, Lavandula Angustifolia (Lavender) Flower/Leaf/ Stem Extract, Vitis Vinifera (Grape) Fruit Extract, Glycine Soja (Soybean) Oil

Vertra

30

Beach Break Daily Facial Moisturizer

Broad Spectrum SPF 30

Water Resistant (40 minutes)

1.6 FL OZ / 45.36 mL

Beach break outer

BEACH BREAK 2-IN-1 DAILY FACIAL MOISTURIZER SUNSCREEN SPF 30 
homosalate, octisalate, avobenzone, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71014-038
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE8 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
GLYCERIN (UNII: PDC6A3C0OX)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
SODIUM GLUCONATE (UNII: R6Q3791S76)  
STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: PN88NW0KPK)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
CETEARYL OLIVATE (UNII: 58B69Q84JO)  
FERULIC ACID (UNII: AVM951ZWST)  
LINALOOL, (-)- (UNII: 3U21E3V8I2)  
NIACINAMIDE (UNII: 25X51I8RD4)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SORBITAN OLIVATE (UNII: MDL271E3GR)  
SOYBEAN OIL (UNII: 241ATL177A)  
TOCOPHEROL (UNII: R0ZB2556P8)  
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
WINE GRAPE (UNII: 3GOV20705G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71014-038-0145.36 mL in 1 BOTTLE; Type 0: Not a Combination Product09/21/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02009/21/2022
Labeler - EAI-JR 286 (827896718)

Revised: 5/2023
Document Id: fc88aa8e-a208-0a80-e053-6394a90a5490
Set id: e72bade7-af0f-af6d-e053-2a95a90aaebc
Version: 3
Effective Time: 20230525
 
EAI-JR 286