Coral Sure Sunscreen
FDA Label NDC 79811-101

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Eponine Labs Llc for the product Coral Sure Sunscreen (NDC 79811-101). 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 ingredients, purpose, uses, warnings, otc - keep out of reach of children, directions, inactive ingredient, questions? comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Zinc Oxide 25.2%

Purpose

SUNSCREEN

Uses

• helps prevent sunburn.

• 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
  • do not use on damaged or broken skin
  • stop use and ask a doctor if rash occurs
  • 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 40 minutes of swimming or sweating • Immediately
after towel drying • At least every 2 hours • Children under 6 months: ask a doctor.

Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk the CDC recommends regular use of sunscreen with a broad spectrum SPF value of 15 or higher, with both UVA and UVB (broad spectrum) protection, 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 Ingredient

Water, Caprylic/Capric Triglyceride, C13-15 Alkane, Polyhydroxystearic Acid, Isostearic Acid, Lecithin, Polyglyceryl-3 olyricinoleate, Capryloyl Glycerin/Sebacic Acid Copolymer, Ethylcellulose, Butyloctyl Salicylate, Sorbitol, Erythritol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Glyceryl Behenate, Glyceryl Caprylate, Polyglyceryl-10 Mono/Dioleate, Pentylene Glycol, C13-C14 Alkane, C15-C23 Alkane, Glycerin, Decyl Glucoside, Vitis Vinifera (Grape) Seed Oil, Magnolia Officinalis Bark Extract, Fragrance, Oryza Sativa (Rice) Bran Extract, Helianthus Annuus (Sunflower) Extract, Tocopherol (Vitamin E), Rosmarinus Officinalis (Rosemary) Leaf Extract, Aloe Barbadensis (Aloe Vera) Leaf Juice, Sodium Hyaluronate, Bisabolol, Argania Spinosa Kernel Oil, Tocopheryl Acetate, Diisopropyl Sebacate, Lauryl Lactate, Isodecyl Neopentanoate, Diisopropyl Adipate

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