FDA.reportPublic FDA data

CARIBBEAN SOL - FACES ONLY - SPF 20

Manufacturer
Pro Skin Solutions, Inc. DBA Active Cosmetics Manufacturing
Effective date
2021-11-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:26:00

Label at a glance#

ProductCARIBBEAN SOL - FACES ONLY - SPF 20
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) 12%

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 Barbadensis (Aloe Vera) Leaf Juice, Ethylhexyl Palmitate, C12-15 Alkyl Benzoate, Sorbitan Sesquioleate, Neopentyl Glycol Diheptanoate, Oryza Sativa (Rice) Bran Wax, Helianthus Annuus (Sunflower) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Ricinus Communis (Castor) Seed Oil, Dipolyhydroxystearate, Propylene Glycol, Glycerin, Algae Extract, Cucumis Sativus (Cucumber) Fruit Extract, Ginkgo Biloba Extract, Tocopherol, Chondrus Crispus (Carrageenan), Magnesium Sulfate, Xanthan Gum, Caprylic Acid, Lauric Acid, Propanediol, Potassium Sorbate, Citrus Sinensis (Sweet Orange) Oil, Rosa Canina (Rosehip) Fruit Oil, Santalum Album (Sandalwood) 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 • No Parabens • Mineral Ingredients

NATURAL
BIODEGRADABLE
REEF FRIENDLY

Water Resistant

BROAD SPECTRUM

"This tube is made from Sustainable Materials"

MADE IN THE USA

Manufactured for: Caribbean Sol Int., LLC
Orlando, FL 32819
407-872-5465 - www.caribbean-sol.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
15464-000915464-0009-1, 15464-0009-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
ALOE VERA LEAFZY81Z83H0XIACT
ETHYLHEXYL PALMITATE2865993309IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
RICE BRANR60QEP13ICIACT
SUNFLOWER OIL3W1JG795YIIACT
JOJOBA OIL724GKU717MIACT
CASTOR OILD5340Y2I9GIACT
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW)9713Q0S7FOIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
LAMINARIA DIGITATA15E7C67EE8IACT
CUCUMBERYY7C30VXJTIACT
GINKGO19FUJ2C58TIACT
TOCOPHEROLR0ZB2556P8IACT
CHONDRUS CRISPUS CARRAGEENANUE856F2T78IACT
MAGNESIUM SULFATE, UNSPECIFIEDDE08037SABIACT
XANTHAN GUMTTV12P4NEEIACT
CAPRYLIC ACIDOBL58JN025IACT
LAURIC ACID1160N9NU9UIACT
PROPANEDIOL5965N8W85TIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
CITRUS SINENSIS FLOWER OILAJ56JP5TFPIACT
ROSA CANINA FRUIT OILCR7307M3QZIACT
SANDALWOOD OILX7X01WMQ5FIACT

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
517b3d98-7c33-4203-8236-6f49cdd329a31ff6a721-b734-482d-8ae4-2a953447de9b2021-11-17WarningsExact identifier
spl id: 517b3d98-7c33-4203-8236-6f49cdd329a3
spl set id: 1ff6a721-b734-482d-8ae4-2a953447de9b

Reported adverse events (FAERS/openFDA)#

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