FDA.reportPublic FDA data

HAWAIIAN SOL Natural Sunscreen Spray SPF-30

Manufacturer
Caribbean Sol International, LLC
Effective date
2023-11-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:00:03

Label at a glance#

ProductHAWAIIAN SOL Natural Sunscreen SPF-30
Active ingredientZINC OXIDE
Label structure7 sections

Indications and 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

Dosage and administration

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,...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 16%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

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.

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash ocuurs

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

DOSAGE & ADMINISTRATION SECTION

  • 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:

INACTIVE INGREDIENT SECTION

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

SPL UNCLASSIFIED SECTION

protect this product from excessive heat and direct sun

Claims:

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

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

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
82520-263-00HAWAIIAN SOL Natural Sunscreen SPF-30177.44 mL in 1 CANSOLUTION177.442

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82520-263HAWAIIAN SOL NATURAL SUNSCREEN SPF-30 (ZINC OXIDE) SOLUTION [CARIBBEAN SOL INTERNATIONAL, LLC]2Current NDC, Legacy NDC, 1 package rows20231112_3c43fe36-2c24-4859-a262-8af4d3420e47.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82520-26382520-263-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
ADANSONIA DIGITATA SEED OIL77MKL7AR5IIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
COCONUT3RT3536DHYIACT
COCONUT OILQ9L0O73W7LIACT
CARROTL56Z1JK48BIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
DODECANE11A386X1QHIACT
GLYCERYL LAURATEY98611C087IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
MANGOI629I3NR86IACT
PUNICA GRANATUM ROOT BARKCLV24I3T1DIACT
TOCOPHEROLR0ZB2556P8IACT
TRIDECYL SALICYLATEAZQ08K38Z1IACT
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
HAWAIIAN SOL Natural Sunscreen SPF-30ZINC OXIDECaribbean Sol International, LLC3c43fe36-2c24-4859-a262-8af4d3420e472023-11-11WarningsExact identifier
ndc (package): 82520-263-00
ndc (product): 82520-263
ndc11 (package): 82520026300
spl id: 09e3474c-5795-44f0-e063-6294a90a8568
spl set id: 3c43fe36-2c24-4859-a262-8af4d3420e47

Reported adverse events (FAERS/openFDA)#

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