HAWAIIAN SOL NATURAL SUNSCREEN SPF-30- zinc oxide solution

HAWAIIAN SOL Natural Sunscreen SPF-30 by

Drug Labeling and Warnings

HAWAIIAN SOL Natural Sunscreen SPF-30 by is a Otc medication manufactured, distributed, or labeled by Caribbean Sol International, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Zinc Oxide 16%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun Directions

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 ocuurs

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-------SHAKE WELL--------

• apply liberally 15 minutes before sun exposure
• reapply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours
• 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 SPE of 15 or higher and other sun protection measures including: Sun Protection Measures -
• 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:

Adansonia Digitata (Baobab) Oil, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, cetearyl Alcohol, Citric Acid, Cocos Nucifera (Coconut) Extract, Cocos Nucifera (Coconut) Oil, Daucus Carota Sativa (Carrot) Extract, Decyl Glucoside, Dodecane, Glyceryl Laurate, Glyceryl Stearate, Glyceryl Undecylenate, Hydroxyethylcellu-lose, Laminaria (Algae) Extract, Mangifera Indica (Mango) Butter, Polyhydroxystearic Acid, Punica Granatum (Pomegranate) Extract, Tocopherol (Vitamin E), Tridecyl Salicylate, Xanthan Gum.

Other information

protect this product from excessive heat and direct sun

Claims:

• Mineral Ingredients
• No Animal Testing
• Gluten Free
• No Parabens

Package Labeling:

INGREDIENTS AND APPEARANCE

HAWAIIAN SOL NATURAL SUNSCREEN SPF-30 
zinc oxide solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82520-263
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	160 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ADANSONIA DIGITATA SEED OIL (UNII: 77MKL7AR5I)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCONUT (UNII: 3RT3536DHY)
COCONUT OIL (UNII: Q9L0O73W7L)
CARROT (UNII: L56Z1JK48B)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
DODECANE (UNII: 11A386X1QH)
GLYCERYL LAURATE (UNII: Y98611C087)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
MANGO (UNII: I629I3NR86)
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)
TOCOPHEROL (UNII: R0ZB2556P8)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82520-263-00	177.44 mL in 1 CAN; Type 0: Not a Combination Product	01/24/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/24/2022

Labeler - Caribbean Sol International, LLC (116857302)