TITANIUM DIOXIDE, ZINC OXIDE

Manufacturer
Kapa'ihi, Inc
Effective date
2023-11-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:00:08

Label at a glance#

Productkoa protect our ocean life OXYBENZONE FREE Broad Spectrum SPF 30 UVA UVB Protection Sunscreen
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure7 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. Reapply at least every two-hours or immediately after swimming. sweating or towel drying. SUN PROTECTION MEASURES, Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including: - Wear ...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide (6.00%)

Zinc Oxide (6.00%)

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. 

Stop use and consult physician 

OTC - STOP USE SECTION

if irritation or rash develops. 

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical attention or contact poison control center immediately

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15-minutes before sun exposure. Reapply at least every two-hours or immediately after swimming. sweating or towel drying. SUN PROTECTION MEASURES, Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including: - Wear long sleeve shirts, pants, hats and sunglasses. - For children under 6-months, consult a physician.

OTHER INGREDIENTS

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butyrospermum Parkii (Shea) Butter, Camellia Sinensis (Green Tea) Extract, Cocos Nucifera (Coconut) Oil, Dehydroxanthan Gum, Gluconolactone, Glycerin, Glycine Soja (Soybean) Oil, Helianthus Annuus (Sunflower) Oil, Lecithin, Mangifera Indica (Mango) Seed Butter. Sodium Benzoate, Sodium Laurylglucosides Hydroxypropyl Sulfonate, Styrene/Acrylates Copolymer, Tocopherol Acetate (Vitamin E), Xanthan Gum.

Other Information:

SPL UNCLASSIFIED SECTION

Protect this product from excessive heat and direct sunlight

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label5Label5

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
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71889-350-08koa protect our ocean life OXYBENZONE FREE Broad Spectrum SPF 30 UVA UVB Protection Sunscreen236 mL in 1 BOTTLECREAM2363
71889-350-08koa protect our ocean life OXYBENZONE FREE Broad Spectrum SPF 30 UVA UVB Protection Sunscreen1 in 1 CARTONCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71889-350KOA PROTECT OUR OCEAN LIFE OXYBENZONE FREE BROAD SPECTRUM SPF 30 UVA UVB PROTECTION SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [KAPA'IHI, INC]3Current NDC, Legacy NDC, 2 package rows20231112_66e5eb1b-4ef0-459d-8428-b3e2f221bc85.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71889-35071889-350-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

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
koa protect our ocean life OXYBENZONE FREE Broad Spectrum SPF 30 UVA UVB Protection SunscreenTITANIUM DIOXIDE, ZINC OXIDEKapa'ihi, Inc66e5eb1b-4ef0-459d-8428-b3e2f221bc852023-11-11WarningsExact identifier
ndc (package): 71889-350-08
ndc (product): 71889-350
ndc11 (package): 71889035008
spl id: 09dc25cb-c025-39aa-e063-6394a90a99b2
spl set id: 66e5eb1b-4ef0-459d-8428-b3e2f221bc85

Reported adverse events (FAERS/openFDA)#

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