Solar Defense Body

Solar Defense Body
SPL v5
SPL
SPL Set ID 45ec77c5-5eb3-0e51-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2019-10-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (100 mg) Octisalate (50 mg) Octocrylene (70 mg)
Inactive Ingredients
Alcohol Pineapple Beta Carotene Butylene Glycol Green Tea Leaf Medium-chain Triglycerides Citral Orange Peel Lemon Oil Grapefruit Coconut Coffee Bean Cucumber Glycerin Limonene, (+)- Linalool, (+/-)- Methyl Dihydroabietate Pentylene Glycol Apricot Pear Apple Rosa Canina Fruit Raspberry Thermus Thermophilus Lysate Tocopherol Vanilla Corn

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-01-12

Description

Avobenzone (3%) Homosalate (10%) Octisalate (5%) Octocrylene (7%)

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone (3%) Homosalate (10%) Octisalate (5%) Octocrylene (7%)

Uses
  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions
Directions
  • Apply liberally and evenly 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 value of 15 or higher and other sun protection measures including:
  • Limit itme in the sun, expecially from 10 a.m. - 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses.
  • Children under 6 months of age: Ask a Doctor
Do Not Use

on damaged or broken skin.

Other Information

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

Package Labeling:

Active Ingredients

Avobenzone (3%)

Homosalate (10%)

Octisalate (5%)

Octocrylene (7%)

Inactive Ingredients

Alcohol Denat., Aloe Barbadensis Leaf Juice, Ananas Sativus (Pineapple) Fruit Extract, Beta Carotene, Butter Extract, Butylene Glycol, Camellia Sinensis Leaf Extract, Caprylic/Capric Triglyceride, Citral, Citrus Aurantium Dulcis (Orange) Peel Extract, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Limon (Lemon) Peel Oil, Citrus Paradisi (Grapefruit) Fruit Extract, Cocos Nucifera (Coconut) Fruit Extract, Coffea Arabiaca (Coffee) Leaf/ Seed Extract, Cucumis Sativus (Cucumber) Fruit Extract, Glycerin, Hydrolyzed Yeast Protein, Limonene, Linalool, Methyl Dihydroabietate, Pentylene Glycol, Pichia/Resveratrol Ferment Extract, Prunus Armeniaca (Apricot) Fruit Extract, Pyrus Communis (Pear) Fruit Extract, Pyrus Malus (Apple) Fruit Extract, Rosa Canina Fruit Extract, Rubus Idaeus (Raspberry) Fruit Extract, Thermus Thermophilus Ferment, Tocopherol, Vanilla Planifolia Fruit Extract, Zea Mays (Corn) Oil

Questions Or Comments?

Call 1.800.932.9873

When Using This Product

keep 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.


Structured Label Content

Uses
  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions
Purpose

Sunscreen

Directions
  • Apply liberally and evenly 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 value of 15 or higher and other sun protection measures including:
  • Limit itme in the sun, expecially from 10 a.m. - 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses.
  • Children under 6 months of age: Ask a Doctor
Do Not Use (Do not use)

on damaged or broken skin.

Other Information

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

Package Labeling:

Active Ingredients

Avobenzone (3%)

Homosalate (10%)

Octisalate (5%)

Octocrylene (7%)

Inactive Ingredients

Alcohol Denat., Aloe Barbadensis Leaf Juice, Ananas Sativus (Pineapple) Fruit Extract, Beta Carotene, Butter Extract, Butylene Glycol, Camellia Sinensis Leaf Extract, Caprylic/Capric Triglyceride, Citral, Citrus Aurantium Dulcis (Orange) Peel Extract, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Limon (Lemon) Peel Oil, Citrus Paradisi (Grapefruit) Fruit Extract, Cocos Nucifera (Coconut) Fruit Extract, Coffea Arabiaca (Coffee) Leaf/ Seed Extract, Cucumis Sativus (Cucumber) Fruit Extract, Glycerin, Hydrolyzed Yeast Protein, Limonene, Linalool, Methyl Dihydroabietate, Pentylene Glycol, Pichia/Resveratrol Ferment Extract, Prunus Armeniaca (Apricot) Fruit Extract, Pyrus Communis (Pear) Fruit Extract, Pyrus Malus (Apple) Fruit Extract, Rosa Canina Fruit Extract, Rubus Idaeus (Raspberry) Fruit Extract, Thermus Thermophilus Ferment, Tocopherol, Vanilla Planifolia Fruit Extract, Zea Mays (Corn) Oil

Questions Or Comments? (Questions or comments?)

Call 1.800.932.9873

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 occurs.

Keep Out of Reach of Children. (Keep out of reach of children.)

If product is swallowed, get medical help or contact a Poison Control Center right away.


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Raw Label Data

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