FDA.reportPublic FDA data

Caribbean Beach SPORT Sunscreen

Manufacturer
Industrias Bernal Cantón S.A. de C.V.
Effective date
2023-03-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:34:10

Label at a glance#

ProductCaribbean Beach SPORT Sunscreen
Active ingredientENSULIZOLE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE
Label structure9 sections

Indications and 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.  

Dosage and administration

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 10am to 2pm. Wear long-sleeved shirts, pants, hats and sunglasses. Reapply: after 40 minutes of swimming...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 10am to 2pm.
  • 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

OTHER SAFETY INFORMATION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

210-202-2366

Package labeling: 78239-009-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

tube labeltube label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78239-00978239-009-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
LAURETH-7Z95S6G8201IACT
POLYSORBATE 207T1F30V5YHIACT
TOCOPHEROLR0ZB2556P8IACT
PHENOXYETHANOLHIE492ZZ3TIACT
ALOE VERA LEAFZY81Z83H0XIACT
TRICAPRINO1PB8EU98MIACT
TRICAPRILIN6P92858988IACT
ETHYLCELLULOSE, UNSPECIFIED7Z8S9VYZ4BIACT
DIISOPROPYL ADIPATEP7E6YFV72XIACT
XANTHAN GUMTTV12P4NEEIACT
EDETIC ACID9G34HU7RV0IACT
ENSULIZOLE9YQ9DI1W42ACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f76db82a-8272-92b0-e053-6294a90a8ec668ff03ae-c178-4a46-bae4-a4604576aa4f2023-03-21WarningsExact identifier
spl id: f76db82a-8272-92b0-e053-6294a90a8ec6
spl set id: 68ff03ae-c178-4a46-bae4-a4604576aa4f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.