SPL v2
SPL
SPL Set ID 20755fd4-ad05-4de2-84f5-fb29c0c5b104
Route
TOPICAL
Published
Effective Date 2024-01-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (24.5 g)
Inactive Ingredients
Medium-chain Triglycerides Coco-caprylate Ceresin Butyloctyl Salicylate Polyhydroxystearic Acid (2300 Mw) Tocopherol Coconut Oil Triethoxycaprylylsilane Jojoba Oil Glycerin Aloe Vera Leaf Water Levomenol Shea Butter Calendula Officinalis Flower Chamomile

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-31
Description

Zinc Oxide 24.5%                     Sunscreen

Purpose

Zinc Oxide 24.5%                     Sunscreen

Medication Information

Purpose

Zinc Oxide 24.5%                     Sunscreen

Description

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
Product Label

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

Active Ingredient                  Purpose

Zinc Oxide 24.5%                     Sunscreen

Structured Label Content

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
Product Label (Product label)

Other Information (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 (Questions or comments)

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

Active Ingredient                  Purpose (Active ingredient                  Purpose)

Zinc Oxide 24.5%                     Sunscreen

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:10.681353 · Updated: 2026-03-14T23:12:20.443473