FDA.reportPublic FDA data

Hawaii Sol Natural Non-Nano Sunscreen Spray SPF 50

Manufacturer
Caribbean Sol International, LLC | Pure Source, LLC
Effective date
2026-05-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:56:48

Label at a glance#

ProductHawaii Sol Natural Non-Nano Sunscreen SPF 50
Active ingredientZINC OXIDE
Label structure8 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 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...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 15.00%

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

OTC - DO NOT USE SECTION

  • on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

  •  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

OTC - STOP USE SECTION

  • rash or irritation develops and lasts.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Directions.

DOSAGE & ADMINISTRATION SECTION

  • 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.

SPL UNCLASSIFIED SECTION

  • Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

(407) 872-5465

Package labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label02.jpgLabel02.jpg

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82520-957-00Hawaii Sol Natural Non-Nano Sunscreen SPF 50177 mL in 1 CANLIQUID1771

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
82520-95782520-957-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALLANTOIN344S277G0ZIACT
ALOE VERA LEAF JUICERUE8E6T4NBIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
C13-16 ISOPARAFFINLED42LZG6OIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SAFFLOWER OIL65UEH262ISIACT
CHAMOMILEFGL3685T2XIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
WATERMELON231473QB6RIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
DODECANE11A386X1QHIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL STEARATE CITRATEWH8T92A065IACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
HEPTYL UNDECYLENATEW77QUB6GXOIACT
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATED2QHA03458IACT
NIACINAMIDE25X51I8RD4IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
PROPANEDIOL5965N8W85TIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TRIDECYL SALICYLATEAZQ08K38Z1IACT
WATER059QF0KO0RIACT
XANTHAN GUMTTV12P4NEEIACT
ZINC OXIDESOI2LOH54ZACTIM

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
Hawaii Sol Natural Non-Nano Sunscreen SPF 50ZINC OXIDECaribbean Sol International, LLC24678326-547f-427d-a481-d8c40380e30a2026-05-12WarningsExact identifier
ndc (package): 82520-957-00
ndc (product): 82520-957
ndc11 (package): 82520095700
spl id: 519db51a-755f-19c1-e063-6294a90ace6f
spl set id: 24678326-547f-427d-a481-d8c40380e30a

Reported adverse events (FAERS/openFDA)#

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