230cc36d-5163-f423-e063-6394a90a8124

SPL v2
SPL
SPL Set ID 230cc36d-5163-f423-e063-6394a90a8124
Route
topical
Published
Effective Date 2021-05-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (0.6 g)
Inactive Ingredients
coco-caprylate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2021-05-20

Description

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.


Medication Information

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 occurs.

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.
Directions

For sunscreen use:

  • Apply liberally 15 minutes before sun exposure
  • Reapply at least every 2 hours
  • Use a water-resistant sunscreen if swimming or sweating.
Description

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.

Section 50565-1

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 51945-4

Non-Nano Uncoated Zinc Oxide 20.0%

Inactive Ingredients:

Water, Coco-Caprylate, Dicaprylyl Carbonate, Glycerin, Microcrystalline Cellulose, Lauryl Glucoside, Chamomilla Recutita (Matricaria) Flower Extract*, Calendula Officinalis (Marigold) Flower Extract*, Caprylic/Capric Triglyceride, Polyglyceryl-2 Dipolyhydroxystearate, Capryloyl Glycerin/Sebacic Acid Copolymer, Glyceryl Caprylate, Phytic Acid, Cellulose Gum, Xanthan Gum, Polyhydroxystearic Acid, Cetyl Alcohol, Simmondsia Chinensis (Jojoba) Seed Oil*, Diheptyl Succinate, Triethoxycaprylylsilane, Glyceryl Isostearate, Glyceryl Stearate, Camellia Sinensis (Green Tea) Leaf Extract*, Caprylhydroxamic Acid.

*Certified Organic Ingredients

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 value of 15 or higher and other sun protection measures including:

  • limit time in the sun, especially from 10am -2pm
  • wear long-sleeved shirt, pants, hats and sunglasses

Children under 6 months of age: Ask a doctor


Structured Label Content

Warnings (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 occurs.

Uses (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.
Directions (DIRECTIONS)

For sunscreen use:

  • Apply liberally 15 minutes before sun exposure
  • Reapply at least every 2 hours
  • Use a water-resistant sunscreen if swimming or sweating.
Section 50565-1 (50565-1)

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 51945-4 (51945-4)

Non-Nano Uncoated Zinc Oxide 20.0%

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Water, Coco-Caprylate, Dicaprylyl Carbonate, Glycerin, Microcrystalline Cellulose, Lauryl Glucoside, Chamomilla Recutita (Matricaria) Flower Extract*, Calendula Officinalis (Marigold) Flower Extract*, Caprylic/Capric Triglyceride, Polyglyceryl-2 Dipolyhydroxystearate, Capryloyl Glycerin/Sebacic Acid Copolymer, Glyceryl Caprylate, Phytic Acid, Cellulose Gum, Xanthan Gum, Polyhydroxystearic Acid, Cetyl Alcohol, Simmondsia Chinensis (Jojoba) Seed Oil*, Diheptyl Succinate, Triethoxycaprylylsilane, Glyceryl Isostearate, Glyceryl Stearate, Camellia Sinensis (Green Tea) Leaf Extract*, Caprylhydroxamic Acid.

*Certified Organic Ingredients

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 value of 15 or higher and other sun protection measures including:

  • limit time in the sun, especially from 10am -2pm
  • wear long-sleeved shirt, pants, hats and sunglasses

Children under 6 months of age: Ask a doctor


Advanced Ingredient Data


Raw Label Data

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