SPL v2
SPL
SPL Set ID 75763dc1-c762-42fc-a8fe-4d9d7bde0ce6
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 %

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 24.5 %

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 useon damaged or broken skin
  • When using this productkeep out of eyes. Rinse with water to remove
  • Stop use and ask a doctor if 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:

•limiting 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.

Do Not Use
  • on damaged or broken skin.
Drug Facts

Product Label

Active Ingredient

Zinc Oxide 24.5 %

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.botaobaby.com

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.


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
Purpose

Sunscreen

Warnings (warnings)
  • For external use only
  • Do not useon damaged or broken skin
  • When using this productkeep out of eyes. Rinse with water to remove
  • Stop use and ask a doctor if 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:

•limiting 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.

Do Not Use (Do not use)
  • on damaged or broken skin.
Drug Facts

Product Label (Product label)

Active Ingredient

Zinc Oxide 24.5 %

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 (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.botaobaby.com

When Using This Product, (When using this product,)
  • Keep out of eyes. Rinse with water to remove.
Stop Use and Ask A Doctor (Stop use and ask a doctor)
  • if rash or irritation develops and lasts.
Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, call a poison control center or get medical help right  away.


Advanced Ingredient Data


Raw Label Data

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