Bion 4 FLOZ Pure Mineral Sunscreen SPF 30

Manufacturer
CA-Botana International INC
Effective date
2025-12-16
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
monthly-update
Hydrated at
2026-06-03 17:46:08

Label at a glance#

ProductBion 4 FLOZ Pure Mineral Sunscreen SPF 30
Active ingredientZINC OXIDE
Label structure9 sections

Label contents#

Full prescribing information#

Warning & Precautions

WARNINGS AND PRECAUTIONS SECTION

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 occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a poison control center right away.

Dosage & Administration

DOSAGE & ADMINISTRATION SECTION

Helps prevent sunburn. If used as directed with other sun protection measured decreases the risk of skin cancer and early skin aging caused by the sun. Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply: at least 2 hours. Children under 6 months: Ask a doctor. Sun protection measurements. 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 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-sleeve shirts, pants, hats, and sunglasses. Protect this product from excessive heat and direct sun

Inactive Ingredients

INACTIVE INGREDIENT SECTION

] Hyaluronic Acid, Cetearyl Alcohol,Glycerin, Horse Chestnut, Vanilla Planifolia Fruit, Xanthan Gum, Hydrated Silica, Alkyl (C12-15) Benzoate, Phenoxyethanol, Triethoxycaprylylsilane, Potassium Sorbate, Beeswax, Ascorbyl Palmitate, Stearic Acid, Ceteareth-15, Macadamia Ternifolia Seed oil, Mica, Isomalt, Green tea leaf. Polyhidroxystearic acid stearate, Olea Europaea (Olive) leaf powder, Vitis Vinifera (Grape) seed oil, Ascorbic Acid, Propanediol, .Alpha.-Tocopherol Acetate, D, Ethylhexylglycerin, Lecithin, Soybean, Caprylic/Capric Triglyceride,Tocopherol, Aloe, Decyl Oleate, Ethylhexyl Palmitate, Water, Shea Butter, Rosmarinus Officinalis (Rosemary) Leaf powder, Panthenol, Phosphatidylcholine, Soybean, Citric Acid, Orange oil, Niacinamide, Stearyl Alcohol, Centella Asiatica, Coco-Caprilate/Caprate, Phytate Sodium.

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 19 %

Purpose

OTC - PURPOSE SECTION

Sunscreen, helps prevent sunburn

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of children section [OTC - KEEP OUT OF REACH OF CHILDREN SECTION] For external use only.

Avoid contact with eyes.

Keep out of reach of children.

Do not apply to open wounds.

STOP USE AND ask a doctor if condition worsens or

symptoms persist for more than seven days, discontinue

use of the product

Warnings

WARNINGS SECTION

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 occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a poison control center right away.

Indications & Usage

INDICATIONS & USAGE SECTION

Helps prevent sunburn. If used as directed with other sun protection measured decreases the risk of skin cancer and early skin aging caused by the sun. Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply: at least 2 hours. Children under 6 months: Ask a doctor. Sun protection measurements. 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 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-sleeve shirts, pants, hats, and sunglasses. Protect this product from excessive heat and direct sun

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2025_pure mineral Sunscreen Broad spectru2025_pure mineral Sunscreen Broad spectru

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
35192-06035192-060-13

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 46 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.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4b3400ba-8402-8aea-e063-6394a90a80cc34a80e5c-7ea0-d430-e063-6394a90aae392026-02-19WarningsExact identifier
spl set id: 34a80e5c-7ea0-d430-e063-6394a90aae39

Reported adverse events (FAERS/openFDA)#

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