Sun And Shine Mineral Sunscreen Cream
FDA Label NDC 69435-1505

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Peer Pharm Ltd. for the product Sun And Shine Mineral Sunscreen (NDC 69435-1505). 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, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Zinc Oxide 24.5%

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.
  • 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, call a poison control center or get medical help 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
• 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 of 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10 am to 2 p.m.
• wear long-sleeve shirts, pants, hats, and sunglasses
• Children under 6 months: ask a doctor

Other Information

protect this product from excessive heat and sun

Inactive Ingredients

aqua, coco-caprylate, styrene/acrylates copolymer, octyldodecyl citrate crosspolymer, cetearyl olivate, sorbitan olivate, caprylyl glycol, glycerin, polyhydroxystearic acid, aloe barbadensis leaf juice, panthenol, triethoxycaprylylsilane, cetearyl alcohol, tocopherol, butyrospermum parkii (shea) butter, silica, silica dimethyl silylate, xanthan gum, caprylhydroxamic acid, propanediol, sodium phytate, dipotassium glycyrrhizate, chamomilla recutita (matricaria) flower extract, calendula officinalis flower extract, citric acid

Questions Or Comments

Call 951-297-7976 or visit www.kcare.co.il

Product Label

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