Plsf-1831 Wrinkle Repair Moisturizer Spf 30

Plsf-1831 Wrinkle Repair Moisturizer Spf 30
SPL v5
SPL
SPL Set ID a067e968-e598-40ef-95f2-c338b5e413dd
Route
TOPICAL
Published
Effective Date 2023-08-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (2 g) Homosalate (4 g) Octisalate Octocrylene
Inactive Ingredients
Water Trisiloxane Isononyl Isononanoate Glycerin Steareth-21 Nylon-12 Silicon Dioxide Cetyl Alcohol Stearyl Alcohol Glyceryl Stearate Se Peg-100 Stearate Phenoxyethanol Ethylhexylglycerin Dimethicone Crosspolymer (450000 Mpa.s At 12% In Cyclopentasiloxane) Styrene/acrylamide Copolymer (500000 Mw) Myrtus Communis Top Xanthan Gum Vitamin A Palmitate Polysorbate 20 Edetate Disodium Anhydrous Ascorbic Acid Sodium Hydroxide Butylated Hydroxytoluene Hyaluronic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-08-11

Description

Avonenzone 2%                                Sunscreen Homosalate 4%                                Sunscreen Octisalate 4%                                   Sunscreen Octocrylene  2%                               Sunscreen           

Purpose

Avonenzone 2%                                Sunscreen Homosalate 4%                                Sunscreen Octisalate 4%                                   Sunscreen Octocrylene  2%                               Sunscreen           


Medication Information

Purpose

Avonenzone 2%                                Sunscreen Homosalate 4%                                Sunscreen Octisalate 4%                                   Sunscreen Octocrylene  2%                               Sunscreen           

Description

Avonenzone 2%                                Sunscreen Homosalate 4%                                Sunscreen Octisalate 4%                                   Sunscreen Octocrylene  2%                               Sunscreen           

Uses

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

Section 51945-4

Section 55105-1

Warnings

Directions:

• apply liberal 15 minutes before sun exposure• reapply at least every 2 hours •use a water resistant sunscreen if swimmingor sweating•children under 6 months of age: ask a doctor• Sun Protection Measures:Spending time in the sun increase your risk of skin cancer and early skin aging. To decrease this risk. regularly usea sunscreen wrtha Broad Spectrum SPF value of15 or higher and other suncrin protection measures including:

• limrt time in the sun, especial from 10a.m. -2 p.rn.•wear long-sleeve shorts , pants, hats and sunglasses

Do Not Use On

• damaged or broken skin.

Inactive Ingredients

When Using This Product

•keep out of eyes. Rinse with waterto remove.

Stop Use and Ask A Doctor

• if rash occurs.

Active Ingredients                              Purpose

Avonenzone 2%                                Sunscreen

Homosalate 4%                                Sunscreen

Octisalate 4%                                   Sunscreen

Octocrylene  2%                               Sunscreen           

Keep Out of Reach of Children. If Swallowed,get Medical Help Orcontact A Poison Control Center Right Away


Structured Label Content

Uses

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

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Warnings

Directions:

• apply liberal 15 minutes before sun exposure• reapply at least every 2 hours •use a water resistant sunscreen if swimmingor sweating•children under 6 months of age: ask a doctor• Sun Protection Measures:Spending time in the sun increase your risk of skin cancer and early skin aging. To decrease this risk. regularly usea sunscreen wrtha Broad Spectrum SPF value of15 or higher and other suncrin protection measures including:

• limrt time in the sun, especial from 10a.m. -2 p.rn.•wear long-sleeve shorts , pants, hats and sunglasses

Do Not Use On (Do not use on)

• damaged or broken skin.

Inactive Ingredients

When Using This Product (When using this product)

•keep out of eyes. Rinse with waterto remove.

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

• if rash occurs.

Active Ingredients                              Purpose (Active ingredients                              Purpose)

Avonenzone 2%                                Sunscreen

Homosalate 4%                                Sunscreen

Octisalate 4%                                   Sunscreen

Octocrylene  2%                               Sunscreen           

Keep Out of Reach of Children. If Swallowed,get Medical Help Orcontact A Poison Control Center Right Away (Keep out of reach of children. If swallowed,get medical help orcontact a Poison Control Center right away)


Advanced Ingredient Data


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