Caribbean Beach KIDS Sunscreen

Caribbean Beach KIDS Sunscreen by

Drug Labeling and Warnings

Caribbean Beach KIDS 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 KIDS 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 KIDS 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 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

• 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: 78239-008-01

CARIBBEAN BEACH KIDS SUNSCREEN 
ensulizole, octinoxate, octisalate, octocrylene, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78239-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	40 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	70 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	60 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78239-008-01	1 in 1 BOX	07/22/2022	04/01/2023
1		250 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/22/2022	04/01/2023

Labeler - Industrias Bernal Cantón S.A. de C.V. (812827340)

Revised: 3/2023

Document Id: f76dc37e-481e-980d-e053-6394a90a2e63

34390-5

Set id: 17661645-cbab-4457-956d-c70776e64062

Version: 2

Effective Time: 20230321