Tiger Baby Baby Sunscreen Spf-50 Cream
FDA Label NDC 82247-278

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Brickell Brands Llc for the product Tiger Baby Baby Sunscreen Spf-50 (NDC 82247-278). 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 active ingredient, purpose, uses:, warnings:, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Zinc Oxide 20.00%

Purpose

Sunscreen

Uses:

• Helps prevent sunburn • Higher SPF gives more sunburn protection • 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:

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 or irritation develops and lasts.

Keep Out Of Reach Of Children.

  • If swallowed, get medical help, or contact a Poison Control Center right away.

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Directions:

• 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.

• 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 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.

Inactive Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Camellia  Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl/Capryl Glucoside, Cetearyl Olivate, Citrullus Lunatus (Watermelon) Extract, Cocos Nucifera (Coconut) Oil, Daucus Carota Sativa (Carrot) Extract, Gluconolactone, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, Hyaluronic Acid, Hydroxyethylcellulose, Olea Europaea (Olive) Oil, Persea Gratissima (Avocado) Oil, Polyhydroxystearic Acid, Sodium  Benzoate, Sorbitan Olivate, Stearic Acid, Tocopherol (Vitamin E), Xanthan Gum, Zemea (Corn) Propanediol

Package Labeling:5Ml

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Package Labeling:89Ml

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