Sun And Shine - Mineral Sunscreen Clear Facial Stick Spf 50 Stick
FDA Label NDC 69435-1509

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 Clear Facial Stick Spf 50 (NDC 69435-1509). 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, other information, inactive ingredients, questions or comments, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient                  Purpose

Zinc Oxide 24.5%                     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 a rash occurs
  • Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away

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 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 a.m. to 2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses
  • Children under 6 months: ask a doctor

Other Information

protect this product in this container from excessive heat and direct sun. Do not use if the seal is broken.

Inactive Ingredients

Caprylic/Capric Triglyceride, Coco-Caprylate, Ozokerite, Butyloctyl Salicylate,
Polyhydroxystearic Acid, Tocopherol, Cocos Nucifera (Coonut) Oil, Triethoxycaprylylsilane, Simmondsia Chinensis (Jojoba) Seed Oil, Glycerin, Aloe Barbadensis (Aloe Vera) Leaf Juice, Water (Aqua), Bisabolol, Butyrospermum Parkii (Shea) Butter, Calendula Offcinalis(Calendula) Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract

Questions Or Comments

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

Product Label

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