CARIBBEAN SOL NATURAL NON-NANO SUNSCREEN SPF 50- zinc oxide liquid

Drug Labeling and Warnings

Drug Details [pdf]

Drug Facts

Active Ingredient

Zinc Oxide 15.00%

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.
• Do not puncture or incinerate. Contents under pressure. Do not store it at temperatures above 120°F.

Stop use and ask a doctor if

• rash or irritation develops and lasts.

Keep out of reach of children.

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

If pregnant or breast-feeding,

ask a health professional before use.

Directions.

• Apply liberally 15 minutes before sun exposure and as needed.
• Children under 6 months of age: ask a doctor.
• Reapply: after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours
• do not spray your face directly. Spray into hands and apply to face.
• Use in well-ventilated areas.
• Sun Protection Measures - Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum of 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-sleeved shirts, pants, hats, and sunglasses

Other Information.

• Protect this product from excessive heat and direct sun.

Inactive Ingredients:

Allantoin, Aloe Barbadensis Leaf Juice, Butyloctyl Salicylate, C13-16 Isoalkane, Camellia Sinensis Leaf Extract, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Seed Oil, Chamomilla Recutita (Matricaria) Flower Extract, Citric Acid, Citrullus Lanatus (Watermelon) Fruit Extract, Decyl Glucoside, Dodecane, Glycerin, Glyceryl Stearate Citrate, Glyceryl Stearate SE, Heptyl Undecylenate, Leuconostoc/Radish Root Ferment Filtrate, Niacinamide, Polyhydroxystearic Acid, Propanediol, Sorbitan Stearate, Tocopheryl Acetate, Tridecyl Salicylate, Water (Aqua), Xanthan Gum..

Questions?

(407) 872-5465

Package labeling:

INGREDIENTS AND APPEARANCE

CARIBBEAN SOL NATURAL NON-NANO SUNSCREEN SPF 50 
zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82520-956
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	150 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF JUICE (UNII: RUE8E6T4NB)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
C13-16 ISOPARAFFIN (UNII: LED42LZG6O)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SAFFLOWER OIL (UNII: 65UEH262IS)
CHAMOMILE (UNII: FGL3685T2X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATERMELON (UNII: 231473QB6R)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
DODECANE (UNII: 11A386X1QH)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
NIACINAMIDE (UNII: 25X51I8RD4)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
PROPANEDIOL (UNII: 5965N8W85T)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82520-956-00	177 mL in 1 CAN; Type 0: Not a Combination Product	04/22/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/22/2026

Labeler - Caribbean Sol International, LLC (116857302)

Registrant - Pure Source, LLC (080354456)