FDA.reportPublic FDA data

CARIBBEAN SOL - SUNSCREEN SPF 8

Manufacturer
Pro Skin Solutions, Inc. DBA Active Cosmetics Manufacturing
Effective date
2021-11-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:26:14

Label at a glance#

ProductCARIBBEAN SOL - SUNSCREEN SPF 8
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) 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 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, Fragrance (Parfum).
*= 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-003sunscreen-003

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
15464-000315464-0003-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
ALOE VERA LEAFZY81Z83H0XIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SUNFLOWER OIL3W1JG795YIIACT
CETYL ESTERS WAXD072FFP9GUIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
GLYCERINPDC6A3C0OXIACT
POLYAMIDE-3 (12000 MW)L7P3YWF22XIACT
CETYL ALCOHOL936JST6JCNIACT
CASTOR OILD5340Y2I9GIACT
ETHYLHEXYL PALMITATE2865993309IACT
SHEA BUTTERK49155WL9YIACT
ROSA CANINA FRUIT OILCR7307M3QZIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
OLIVE OIL6UYK2W1W1EIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CHAMOMILEFGL3685T2XIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
PASSIFLORA EDULIS SEED OILF3VOA31UHQIACT
POMEGRANATE SEED OIL0UI45XV0T6IACT
CAPRYLIC ACIDOBL58JN025IACT
LAURIC ACID1160N9NU9UIACT
PROPANEDIOL5965N8W85TIACT
POTASSIUM SORBATE1VPU26JZZ4IACT

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
a4a1b7c5-72bd-4f28-9bad-28f4583deff93a853ab4-225a-4952-893b-b22ebf1b4d8c2021-11-15WarningsExact identifier
spl id: a4a1b7c5-72bd-4f28-9bad-28f4583deff9
spl set id: 3a853ab4-225a-4952-893b-b22ebf1b4d8c

Reported adverse events (FAERS/openFDA)#

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