CARIBBEAN SOL - FACES ONLY - SPF 20

CARIBBEAN SOL - FACES ONLY - SPF 20 by

Drug Labeling and Warnings

CARIBBEAN SOL - FACES ONLY - SPF 20 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 - FACES ONLY - SPF 20- zinc oxide lotion 
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.

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CARIBBEAN SOL - FACES ONLY - SPF 20

Drug Facts

Active Ingredient

Zinc Oxide (Non-Nano) 12%

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 product is swallowed, get medical help or contact a Poison Control center right away.

Directions

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:

*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

protect this product from excessive heat and direct sun

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

CARIBBEAN SOL - FACES ONLY - SPF 20 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 15464-0009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	12 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
RICE BRAN (UNII: R60QEP13IC)
SUNFLOWER OIL (UNII: 3W1JG795YI)
JOJOBA OIL (UNII: 724GKU717M)
CASTOR OIL (UNII: D5340Y2I9G)
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
LAMINARIA DIGITATA (UNII: 15E7C67EE8)
CUCUMBER (UNII: YY7C30VXJT)
GINKGO (UNII: 19FUJ2C58T)
TOCOPHEROL (UNII: R0ZB2556P8)
CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
XANTHAN GUM (UNII: TTV12P4NEE)
CAPRYLIC ACID (UNII: OBL58JN025)
LAURIC ACID (UNII: 1160N9NU9U)
PROPANEDIOL (UNII: 5965N8W85T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CITRUS SINENSIS FLOWER OIL (UNII: AJ56JP5TFP)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
SANDALWOOD OIL (UNII: X7X01WMQ5F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 15464-0009-1	56 g in 1 TUBE; Type 0: Not a Combination Product	11/17/2021
2	NDC: 15464-0009-2	113 g in 1 TUBE; Type 0: Not a Combination Product	11/17/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/17/2021

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(15464-0009)

Revised: 11/2021

Document Id: 517b3d98-7c33-4203-8236-6f49cdd329a3

34390-5

Set id: 1ff6a721-b734-482d-8ae4-2a953447de9b

Version: 1

Effective Time: 20211117

 

Pro Skin Solutions,