CARIBBEAN SOL - SUNSCREEN SPF 30

CARIBBEAN SOL - SUNSCREEN SPF 30 by

Drug Labeling and Warnings

CARIBBEAN SOL - SUNSCREEN 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 - SUNSCREEN SPF 30- 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 - SUNSCREEN SPF 30

Drug Facts

Active Ingredient

Zinc Oxide (Non-Nano) 18%

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 (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, Fragaria Ananassa (Strawberry) Seed 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
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

CARIBBEAN SOL - SUNSCREEN SPF 30 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 15464-0007
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 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CETYL ESTERS WAX (UNII: D072FFP9GU)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
GLYCERIN (UNII: PDC6A3C0OX)
POLYAMIDE-3 (12000 MW) (UNII: L7P3YWF22X)
CETYL ALCOHOL (UNII: 936JST6JCN)
CASTOR OIL (UNII: D5340Y2I9G)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
SHEA BUTTER (UNII: K49155WL9Y)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLIVE OIL (UNII: 6UYK2W1W1E)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CHAMOMILE (UNII: FGL3685T2X)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
PASSIFLORA EDULIS SEED OIL (UNII: F3VOA31UHQ)
POMEGRANATE SEED OIL (UNII: 0UI45XV0T6)
CAPRYLIC ACID (UNII: OBL58JN025)
LAURIC ACID (UNII: 1160N9NU9U)
PROPANEDIOL (UNII: 5965N8W85T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
STRAWBERRY SEED OIL (UNII: 9I73N69W76)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 15464-0007-1	56 g in 1 TUBE; Type 0: Not a Combination Product	11/17/2021
2	NDC: 15464-0007-2	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(15464-0007)

Revised: 11/2021

Document Id: f6f67001-2b22-4670-9b31-fd9cf2541214

34390-5

Set id: 5fb2e528-3675-4654-9a8d-f59b4c88a61b

Version: 1

Effective Time: 20211112

 

Pro Skin Solutions,