Dr. C. Tuna Sun Protector Lip Balm Spf 15 Cream
FDA Label NDC 74690-030

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Farmasi Us Llc for the product Dr. C. Tuna Sun Protector Lip Balm Spf 15 (NDC 74690-030). 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 drug facts:, active ingredients:, purpose:, uses:, warnings:, do not use, other, stop use and ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts:

Active Ingredients:

Homosalate 4,45 %

Ethylhexyl Methoxycinnamate 3,45 %

Purpose:

Sunscreen

Uses:

  • Helps prevent sunburn.

Warnings:

For external use only.

Do Not Use

on damaged or broken skin.

Other

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 swallowed, get medical help or contact a Poison Control Center right away. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. Protects against UVB and UVA rays. This product does not provide 100% protection. Use physical protection (hat, t-shirt, glasses, etc.) Avoid long periods of sun exposure even if you are using sun protection. Keep babies and young children out of direct sunlight. The excessive sun exposure is a major health risk, Discontinue use if signs of irritation or rash occur. Aovid contact with eyes, may cause irritation. 

Directions:

Apply liberally 15 minutes before sun exposure - reapply at least every two hours. Apply morning and night, and as often as needed during the day. Reapply frequently on sun-centric days, and adventures. Sun Protection Measures: Children under 6 months of age: Ask a doctor. Apply before sun exposure. To maintain protection, apply frequently, especially after sweating, swimming or drying off. Apply sufficient amount to the skin.

Other Information:

Protect this product from excessive heat and direct sun.

Inactive Ingredients:

Polyisoprene, C18-70 Isoalkane, Caprylic/Capric Triglyceride, Olus Oil, Synthetic Beeswax, Ceresin, Cetyl Alcohol, Di-C12-15 Alkyl Fumarate, Butyrospermum Parkii Butter, Silica, Aroma/Flavour, Tocopheryl Acetate.

Questions Or Comments?

[email protected] (833) 432-7627 Monday - Friday (9 a.m. -9 p.m. EST)

Package Labeling: Dr. C. Tuna Sun Protector Lip Balm Spf 15, 15Ml/0.5Fl.Oz

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