youth corridor soothe & defend spf-30

youth corridor soothe & defend spf-30
SPL v2
SPL
SPL Set ID 5c0873ff-8e76-48de-919d-f69794c4bd37
Route
topical
Published
Effective Date 2020-12-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octocrylene (80 mg) octisalate (50 mg) zinc cation (30 mg)
Inactive Ingredients
aloe vera leaf water alkyl (c12-15) benzoate c13-14 isoparaffin green tea leaf cetyl alcohol cucumber dimethicone dodecane ethylhexylglycerin glycerin glyceryl monostearate licorice helianthus annuus flowering top laureth-7 peg-100 stearate phenoxyethanol polysorbate 20 almond stearic acid .alpha.-tocopherol acetate trolamine corn

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-12-01

Purpose

Sunscreen

Description

Octocrylene 8.00% Octisalate 5.00% Zinc Oxide 3.00%


Medication Information

Purpose

Sunscreen

Description

Octocrylene 8.00% Octisalate 5.00% Zinc Oxide 3.00%

Questions?

Call (646) 449-8000; or [email protected]

Uses:
  • Helps prevent sunburn.
  • Higher SPF gives more sunburn protection 
  • 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 externel use only.

Do Not Use
  • on damaged or broken skin. 

Drug Facts

Directions:
  • Apply liberally 15 minutes before sun exposure. 
  • Children under 6 months of age:ask a doctor
  • Reapply at least every 2 hours.
  • Reapply as needed or after towel drying, swimming, or sweating
  • Use a water-resistant sunscreen if swimming or sweating.
  • 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: Sun Protection Measures:
  • limit time in the sun, especially from 10a.m. - 2.p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses.
Package Labeling:

Active Ingredients

Octocrylene 8.00%

Octisalate 5.00%

Zinc Oxide 3.00%

Other Information:

Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), C12-15 Alkyl Benzoate, C13-14 Isoparaffin, Camellia Sinesis (Green Tea)Extract, Cetyl Alcohol, Cucumis Sativus (Cuumber) Extract, Dimethicone, Dodecane, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuss(Sunflower)Oil, Laureth-7, PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Polysorbate-20, Prunus Amygdalus, Dulcis (Almond)Oil, Stearic Acid, Tocopherol Acetate (Vitamin E), Triethanolamine, Zemea (Corn) Propanediol.

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, get medical help or contact a Poison Control Center right away.


Structured Label Content

Purpose

Sunscreen

Questions?

Call (646) 449-8000; or [email protected]

Uses:
  • Helps prevent sunburn.
  • Higher SPF gives more sunburn protection 
  • 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 externel use only.

Do Not Use
  • on damaged or broken skin. 

Drug Facts

Directions:
  • Apply liberally 15 minutes before sun exposure. 
  • Children under 6 months of age:ask a doctor
  • Reapply at least every 2 hours.
  • Reapply as needed or after towel drying, swimming, or sweating
  • Use a water-resistant sunscreen if swimming or sweating.
  • 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: Sun Protection Measures:
  • limit time in the sun, especially from 10a.m. - 2.p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses.
Package Labeling:

Active Ingredients

Octocrylene 8.00%

Octisalate 5.00%

Zinc Oxide 3.00%

Other Information: (Other information:)

Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), C12-15 Alkyl Benzoate, C13-14 Isoparaffin, Camellia Sinesis (Green Tea)Extract, Cetyl Alcohol, Cucumis Sativus (Cuumber) Extract, Dimethicone, Dodecane, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuss(Sunflower)Oil, Laureth-7, PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Polysorbate-20, Prunus Amygdalus, Dulcis (Almond)Oil, Stearic Acid, Tocopherol Acetate (Vitamin E), Triethanolamine, Zemea (Corn) Propanediol.

When Using This Product (When using this product)
  • keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If (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, get medical help or contact a Poison Control Center right away.


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Raw Label Data

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