trilipiderm all-body moisture retention cream spf-30

trilipiderm all-body moisture retention cream spf-30
SPL v7
SPL
SPL Set ID 7f34de0a-eeb3-4b71-9abd-53d03266d993
Route
topical
Published
Effective Date 2023-06-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
homosalate (100 mg) octinoxate (75 mg) avobenzone (30 mg) octocrylene (27 mg)
Inactive Ingredients
water butylene glycol calendula officinalis flower safflower caprylyl glycol polyoxyl 20 cetostearyl ether chamomile cholecalciferol dodecane gluconolactone glyceryl monostearate helianthus annuus flowering top hexylene glycol magnesium aluminum silicate meadowfoam estolide o-cymen-5-ol green olive panthenol phenoxyethanol polysorbate 20 potassium sorbate jojoba oil tocopherol trolamine xanthan gum

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-07-03

Purpose

Sunscreen

Description

Homosalate 10% Octinoxate 7.5% Avobenzone 3% Octocrylene 2.7%


Medication Information

Warnings

For external use only.

Uses

• Helps prevent sunburn

• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early againg caused by the sun.

Purpose

Sunscreen

Directions

• Apply liberally 15 minutes before sun exposure • Use a water resistant sunscreen if swimming or sweating • Reapply 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 the time in the sun, especially from 10:00 AM - 2:00 PM • Wear long sleeved shirts, pants, hats, and sunglasses • Children under 6 months: ask a doctor























Other Information

• Protect this product from excessive heat and direct sun

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aqua (Deionized Water), Butylene Glycol, Calendula Officinalis Extract, Carthamus Tinctorius (Safflower) Oil, Caprylyl Glycol, Ceteareth-20, Chamomilla Matricaria (Chamomile) Extract, Cholecalciferol (Vitamin B3), Crambe Abyssinica (Abyssinian) Oil, Dodecane, Gluconolactone, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, Helianthus Annuus (Sunflower) Wax, Hexylene Glycol, Limnanthes Alba (Meadowfoam) Oil, Magnesium Aluminum Silicate, Meadowfoam Estolide, o-Cymen-5-ol, Olea Europaea (Olive) Fruit Unsaponifiables, dl-Panthenol, Partum (Fragrance), Phenoxyethanol, Phytosterols, Polysorbate 20, Potassium Sorbate, Simmondsia Chinensis (Jojoba) Oil, Tocopherol (Vitamin E), Triethanolamine, Xanthan Gum.

Description

Homosalate 10% Octinoxate 7.5% Avobenzone 3% Octocrylene 2.7%

Do Not Use

on damaged or broken skin.

Package Labeling:

Active Ingredients

Homosalate 10% Octinoxate 7.5% Avobenzone 3% Octocrylene 2.7%











Stop Use and Ask Doctor

if rash occurs.

When Using This Product

keep out of eyes. Rinse with water to remove.

Keep Out of Reach of Children.

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


Structured Label Content

Warnings

For external use only.

Uses

• Helps prevent sunburn

• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early againg caused by the sun.

Purpose

Sunscreen

Directions

• Apply liberally 15 minutes before sun exposure • Use a water resistant sunscreen if swimming or sweating • Reapply 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 the time in the sun, especially from 10:00 AM - 2:00 PM • Wear long sleeved shirts, pants, hats, and sunglasses • Children under 6 months: ask a doctor























Other Information

• Protect this product from excessive heat and direct sun

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aqua (Deionized Water), Butylene Glycol, Calendula Officinalis Extract, Carthamus Tinctorius (Safflower) Oil, Caprylyl Glycol, Ceteareth-20, Chamomilla Matricaria (Chamomile) Extract, Cholecalciferol (Vitamin B3), Crambe Abyssinica (Abyssinian) Oil, Dodecane, Gluconolactone, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, Helianthus Annuus (Sunflower) Wax, Hexylene Glycol, Limnanthes Alba (Meadowfoam) Oil, Magnesium Aluminum Silicate, Meadowfoam Estolide, o-Cymen-5-ol, Olea Europaea (Olive) Fruit Unsaponifiables, dl-Panthenol, Partum (Fragrance), Phenoxyethanol, Phytosterols, Polysorbate 20, Potassium Sorbate, Simmondsia Chinensis (Jojoba) Oil, Tocopherol (Vitamin E), Triethanolamine, Xanthan Gum.

Do Not Use (Do not use)

on damaged or broken skin.

Package Labeling:

Active Ingredients

Homosalate 10% Octinoxate 7.5% Avobenzone 3% Octocrylene 2.7%











Stop Use and Ask Doctor (Stop use and ask doctor)

if rash occurs.

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

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.


Advanced Ingredient Data


Raw Label Data

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