Caribbean Beach ADVANCED Sunscreen

Caribbean Beach ADVANCED Sunscreen by

Drug Labeling and Warnings

Caribbean Beach ADVANCED Sunscreen by is a Otc medication manufactured, distributed, or labeled by Industrias Bernal Cantón S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CARIBBEAN BEACH ADVANCED SUNSCREEN- ensulizole, octinoxate, octisalate, octocrylene, titanium dioxide cream 
Industrias Bernal Cantón S.A. de C.V.

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 Beach ADVANCED Sunscreen

Drug Facts

Active ingredients

ENSULIZOLE 4%
OCTINOXATE 7%
OCTISALATE 5%
OCTOCRYLENE 9%
TITANIUM DIOXIDE 5%

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 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 minute before sun exposure.
  • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use sunscreen with Broad Spectrum SPF 15 or higher and other sun protection measures including:
  • Limit time in sun, especially from 10a.m.-2p.m.
  • Wear long-sleeved shirts, pants, hats and sunglasses.
  • Reapply:
  • after 40 minutes of swimming or sweating
  • immediately after towel drying 
  • at least every 2 hours
  • Children under 6 months: Ask a doctor

Other information

  • Protect the product and this container from excessive heat and direct sun.

Inactive ingredients

Water, glycerin, acrylamide/sodium acrylate copolymer, c13-14 isoparaffin, laureth-7, polysorbate 20, tocopherol, phenoxyethanol, aloe vera leaf extract, capric/caprylic triglyceride, ethylcellulose, diisopropyl adipate, xanthan gum and EDTA. 

Questions or comments?

210-202-2366

Package labeling: 78239-007-01

tube label

CARIBBEAN BEACH ADVANCED SUNSCREEN 
ensulizole, octinoxate, octisalate, octocrylene, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 78239-007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE40 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE70 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE60 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
LAURETH-7 (UNII: Z95S6G8201)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
TOCOPHEROL (UNII: R0ZB2556P8)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
TRICAPRIN (UNII: O1PB8EU98M)  
TRICAPRILIN (UNII: 6P92858988)  
ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
XANTHAN GUM (UNII: TTV12P4NEE)  
EDETIC ACID (UNII: 9G34HU7RV0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 78239-007-011 in 1 BOX07/22/202204/01/2023
1250 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/22/202204/01/2023
Labeler - Industrias Bernal Cantón S.A. de C.V. (812827340)

Revised: 3/2023
Document Id: f76da8bd-9947-5d04-e053-6294a90a24e0
Set id: bfa6e3ca-1691-4587-80af-d51660616a85
Version: 2
Effective Time: 20230321