Sunny Skin Super Sun Spf50
FDA Label NDC 83070-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mcdonald Multinational Pty Ltd for the product Sunny Skin Super Sun Spf50 (NDC 83070-001). 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, directions, inactive ingredients, other information, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Zinc Oxide 22.75%

Purpose

Mineral Sunscreen

Uses

Help Prevent Sunburn. If uses as directed with other sun protection measures (see directions) decreases the risk of skin cancer and early ageing caused by the sun

Warnings

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 doctor is rash occurs.

Keep out of reach of children. If swallowed, get medical help or contact a poison control centre right away.

Directions

For sunscreen use: • apply liberally 15 mins before sun exposure • apply to all skin exposed to the sun • use a water resistant sunscreen if swimming or sweating • reapply at least every 2 hours.
Children under 6 months old of age: ask doctor. 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 10 a.m. - 2 p.m. • wear long-sleeved shirts, pants, hats and sunglasses.

Inactive Ingredients

MediumChain(Caprylic/capric) triglycerides, Castor (Ricinus communis) Seed Oil, Coco-octanoate (Coco-caprylate/caprate), Coconut (Cocos nucifera) Oil, Candellila wax, Hydrogenated castor oil, polyglyceryl-3 polyricinoleate, Tocopheryl acetate, Iron oxides, isostearic acid, IBR-TCLC in Jojoba Oil 0705 (Simmondsia Chinensis (Jojoba) Seed Oil (and) Squalane (and) Solanum Lycopersicum (Tomato) Fruit Extract).

Other Information

protect this product from excessive heat and direct sun.

Questions or Comments?
Email [email protected]

Product Label

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