CARIBBEAN SOL - SUNSCREEN SPF 15

Manufacturer
Pro Skin Solutions, Inc. DBA Active Cosmetics Manufacturing
Effective date
2021-11-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:26:28

Label at a glance#

ProductCARIBBEAN SOL - SUNSCREEN SPF 15
Active ingredientZINC OXIDE
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 minutes before sun exposure • reapply:     • after 40 minutes of swimming or sweating     • immediately after towel drying     • at least every 2 hours • Sun Protection Measures - Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including...

Storage and handling

• protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide (Non-Nano) 9%

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 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep Out of Reach of children. If product is swallowed, get medical help or contact a Poison Control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

*Aloe (Vera) Barbadensis Leaf Juice Extract, Fractionated Coconut Oil, Helianthus Annuus (Sunflower) Seed Oil, Cetyl Esters, Sorbitan Sesquioleate, Glycerin (Vegetable derived), Polyamide-3, Cetyl Alcohol, Ricinus Communis (Castor) Seed Oil, Ethylhexyl Palmitate, Butyrospermum Parkii (Shea) Butter, Rosa Canina (Rose Hips) Fruit Oil, Tocopheryl Acetate (Vitamin E), Olea Europaea (Olive) Fruit Oil, Camellia Sinensis (Green Tea) Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Calendula Officinalis Flower Extract, Arnica Montana (Flower) Extract, Passiflora Edulis (Passion Fruit) Oil, Punica Granatum (Pomegranate) Fruit Oil, Caprylic Acid (and), Lauric Acid (and), Propanediol (and), Potassium Sorbate, Citrus Sinensis (Sweet Orange) Essential Oil, Citrus Limonum (Lemon) Essential Oil, Jasminum Officinale (Jasmine) Flower Extract, Hyacinthus Orientalis (Hyacinth) Extract, Vanilla Planifolia Fruit Extract, Santalum Spicatum (Sandalwood) Essential Oil.
*= Certified Organic Ingredient

Other information

STORAGE AND HANDLING SECTION

• protect this product from excessive heat and direct sun

SPL UNCLASSIFIED SECTION

Claims:

• No Animal Testing
• Non-Nano, Uncoated Zinc Oxide
• Gluten Free
• Parabens Free

NATURAL
BIODEGRADABLE
REEF FRIENDLY

Water Resistant

BROAD SPECTRUM

SUSTAINABLE TUBE

MADE IN THE USA

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

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

sunscreen-08sunscreen-08

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
15464-000615464-0006-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

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
64f826be-8997-4456-a61f-212806b293bee4e0a8aa-b978-4807-9c09-4e5d1b5c966e2021-11-16WarningsExact identifier
spl id: 64f826be-8997-4456-a61f-212806b293be
spl set id: e4e0a8aa-b978-4807-9c09-4e5d1b5c966e

Reported adverse events (FAERS/openFDA)#

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