Dermatone Spf 30 Bass Pro Shop Stick
FDA Label NDC 54414-109

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dermatone for the product Dermatone Spf 30 Bass Pro Shop (NDC 54414-109). 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, keep out of reach of children, uses, warnings, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

Avobenzone 3.0%, Homosalate 8.2%, Octinoxate 7.5%, Octocrylenene7.0%................Sunscreen, Dimethicone 2.0.0%...........Skin Protectant

Purpose

Sunscreen, Skin Protectant

Keep Out Of Reach Of Children

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

Uses

Helps prevent sunburns. Helps prevent and temporarily protect dry, chapped or windburned lips.

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown to prevent sunburn, skin cancer and/or early aging.

For external use only: Stop use and ask a doctor: if rash or irritation develops and lasts.

Directions

Apply liberally 15 minutes before sun exposure • 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 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. Children under 6 months: Ask a doctor.

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Euphorbia Cerifera (Candellila) Wax, Fragrance, Helianthus Annuus (Sunflower) Seed Oil, Lanolin, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Menthol, Microcrystalline Wax, Mineral Oil, Ozokerite, Petrolatum, Phenyl Trimethicone, Retinyl Palmitate, Synthetic Beeswax, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate.

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