CARIBBEAN SOL - SPORT® SPF 30

CARIBBEAN SOL - SPORT SPF 30 by

Drug Labeling and Warnings

CARIBBEAN SOL - SPORT SPF 30 by is a Otc medication manufactured, distributed, or labeled by Pro Skin Solutions, Inc. DBA Active Cosmetics Manufacturing. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CARIBBEAN SOL - SPORT SPF 30- zinc oxide liquid 
Pro Skin Solutions, Inc. DBA Active Cosmetics Manufacturing

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.

----------

CARIBBEAN SOL - SPORT® SPF 30

Drug Facts

Active Ingredient

Zinc Oxide 18%

Purpose

Sunscreen

Uses

helps prevent sunburn

Warnings

For external use only

Do not use on damaged or broken skin

Stop use and ask a doctor if rash occurs

Protection Measures - Spending time in the sun increases your risk of skin cancer/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 10 a.m. - 2 p.m. Wear long sleeve shirts, pants, hats, and sunglasses. Children under 6 months ask a doctor.

Keep Out of Reach of Infants. If swallowed, get medical help right away.

Directions

SHAKE WELL

gently wipe, not rub, on areas before sun exposure
reapply:
    after 40 minutes of swimming or sweating
    immediately after towel drying
    at least every 2 hours

Inactive Ingredients:

Organic Aloe Vera (Barbadensis Leaf) Extract, Glyceryl (vegetable based) Stearate, Safflower Oil, Fractionated Coconut Oil, Glycerin (sugar based), Ricinus Communis Oil, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate (Vitamin E), Camellia Sinensis (Green Tea) Extract, Chamomilla Recutita (Matricaria) Extract, Sorbate (Food Grade), Green Coffee Bean Extract (Coffea Arabica Bean Extract), Cucumber Extract (Cucumis Sativus Extract).

NATURAL SUNSCREEN MIST

WITH DRY - GRIP FORMULA

UVA/UVB PROTECTION

ALL NATURAL | ECO FRIENDLY

NATURAL SUN & SKIN CARE

MADE IN USA

For more products & information contact us:
Caribbean Sol Int., LLC
407-872-5465  www.caribbean-sol.com

Packaging

CARIBBEAN SOL - SPORT SPF 30 
zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 15464-0010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	18 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SAFFLOWER OIL (UNII: 65UEH262IS)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERIN (UNII: PDC6A3C0OX)
CASTOR OIL (UNII: D5340Y2I9G)
COCOA BUTTER (UNII: 512OYT1CRR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CHAMOMILE (UNII: FGL3685T2X)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ARABICA COFFEE BEAN (UNII: 3SW678MX72)
CUCUMBER (UNII: YY7C30VXJT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 15464-0010-1	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/18/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/18/2021

Labeler - Pro Skin Solutions, Inc. DBA Active Cosmetics Manufacturing (174120506)

Establishment
Name	Address	ID/FEI	Business Operations
Pro Skin Solutions, Inc. DBA Active Cosmetics Manufacturing		174120506	manufacture(15464-0010)

Revised: 11/2021

Document Id: 4ab1c161-0075-4709-9026-b8f2d930a743

34390-5

Set id: 471db199-a9e2-4e58-b388-bb25b1b16329

Version: 1

Effective Time: 20211118

 

Pro Skin Solutions,