Hello Bello Mineral Sunscreen Lotion
FDA Label NDC 51326-615

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topiderm, Inc. for the product Hello Bello Mineral Sunscreen (NDC 51326-615). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, otc - do not use, otc - stop use, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Active Ingredient

→ Purpose

→ Uses

→ Warnings

→ Otc - Do Not Use

→ Otc - Stop Use

→ Otc - When Using

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions?

→ Principal Display Panel - 148 Ml Bottle Label

Other

Drug Facts

Dist. by Hello Bello Consumer Wellness
2101 Texas Central Pkwy Waco, TX 76712

Active Ingredient

Zinc Oxide 23.5%

Purpose

Sunscreen

Uses

Helps prevent sunburns
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

For external use only.

Otc - Do Not Use

Do not use on damaged or broken skin.

Otc - Stop Use

Stop use and ask a doctor if rash occurs.

Otc - When Using

When using this product keep out of eyes. Rinse with water to remove.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply liberally 15 minutes before sun exposure,

Reapply:

After 80 minutes of swimming or sweating

Immediately after towel drying

At least evert 2 hours when exposed to sun

Sun Protection Measures. 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 value of 15 or higher and other sun protection measures including:

Limit time in the sun, especially from 10 am – 2 pm

Wear long-sleeved shirts, hats and sunglasses

For children under 6 months, ask a doctor

Other Information

Protect this product from excessive heat and direct sun,

May stain or damage some fabrics

Inactive Ingredients

Butyloctyl Salicylate, Calendula Officinalis Flower Extract, Caprylic/Capric Triglyceride, Csprylhydroxamic Acid, Cetyl Dimetehicone, Citrus Aurantium Dulcis (Orange) Peel Oil, Cucumis Sativus (Cucumber) Fruit Extract, Glycerin, Glyceryl Caprylate, /Glyceryl Hydrogenated Rosinate, Hexyl Laurate, Hydrogenated Castor Oil, Magnesium Sulfate, Persea Gratissima (Avocado) Oil, Polyglyceryl-4 Isostearate, Prunus Armeniaca (Apricot) Kernel Oil, Purified Water, Sorbitan Sesquioleate, Triethoxycaprylsilane, Tocopherol, Sodium Hyaluronate,