Preventage Firming Defense Creme Normal/dry Broad Spectrum Spf 15

Preventage Firming Defense Creme Normal/dry Broad Spectrum Spf 15
SPL v3
SPL
SPL Set ID d0dc5744-82d1-2f51-e053-2a95a90a3972
Route
TOPICAL
Published
Effective Date 2021-11-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (1.9 g) Octocrylene (9.4 g)
Inactive Ingredients
Sorbitol Lecithin, Soybean Caprylyl Glycol Butyloctyl Salicylate Sorbitan Monostearate Hexylene Glycol Silicon Dioxide Ethylhexylglycerin Sodium Ursolate Chlorphenesin Dimethicone/vinyl Dimethicone Crosspolymer (hard Particle) Cucumber Trolamine Ginkgo Enoxolone Edetate Disodium Anhydrous Green Tea Leaf Amino Acids Carbomer Homopolymer, Unspecified Type Diethylhexyl Maleate Diazolidinyl Urea Fd&c Red No. 4 Water Phenoxyethanol Povidone Hyaluronic Acid Sodium Oleanolate C10-30 Cholesterol/lanosterol Esters Stearyl Alcohol Biosaccharide Gum-1 Polysorbate 60 Hydrolyzed Bovine Elastin (base; 1000 Mw) Cyclomethicone 5 Phenyl Trimethicone Stearic Acid Dimethicone Ppg-20 Methyl Glucose Ether Alpha-tocopherol Acetate Butylene Glycol Levomenol Cetearyl Methicone (15000 Mw) Dipalmitoyl Hydroxyproline Peg-100 Stearate Calluna Vulgaris Flowering Top Edetate Sodium Methylparaben Glycerin Bis-ethylhexyl Hydroxydimethoxy Benzylmalonate Hamamelis Virginiana Top Vitamin A Palmitate Basic Yellow 5 Imidurea Polyethylene Oxide 300000 Euphrasia Stricta Palmitoyl Hexapeptide-12 Propylene Glycol Ilex Aquifolium Leaf Ascorbyl Palmitate Polyethylene Glycol 400 Alcohol Ruscus Aculeatus Root Echinacea Angustifolia

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-11-15

Description

Active Ingredients (w/w): Purpose Avobenzone 1.9% .........Sunscreen Octocrylene 9.4% ......... Sunscreen


Medication Information

Warnings and Precautions

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.

Indications and Usage

Stop use and ask a doctor if rash occurs.

Dosage and Administration

Directions

For sunscreen use:

apply liberally and evenly 15 minutes before sun exposure

use a water resistant sunscreen if swimming or sweating

reapply at least every 2 hours

children under 6 months: Ask a doctor

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 10 a.m. - 2 p.m.

wear long-sleeved shirts, pants, hats, and sunglasses

Apply to cleansed and toned skin prior to sun exposure

Description

Active Ingredients (w/w): Purpose Avobenzone 1.9% .........Sunscreen Octocrylene 9.4% ......... Sunscreen

Section 44425-7

Other Information

  • protect the product from excessive heat and direct sun
Section 50565-1

Keep out of reach of children

Section 51727-6

Inactive (non-medicinal) ingredients: Aqua/Water/Eau, Glycerin, Butyloctyl Salicylate, Diethylhexyl Maleate, Jojoba Esters, Cyclopentasiloxane, C10-30 Cholesterol/Lanosterol Esters, Phenyl Trimethicone, Stearic Acid, Stearyl Alcohol, Glyceryl Polymethacrylate, Biosaccharide Gum-1, Sorbitan Stearate, Propylene Glycol, Dimethicone, Dipalmitoyl Hydroxyproline, PEG-100 Stearate, Polysorbate 60, PPG-20 Methyl Glucose Ether, Hydrolyzed Malt Extract, Tocopheryl Acetate, Phenoxyethanol, Bis-Ethylhexyl Hydroxydimethoxy Benzylmalonate, Bisabolol, Cetearyl Methicone, Hydrolyzed Elastin, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, PEG-8, Alcohol, Triethanolamine, Sorbital, Lecithin, Caprylyl Glycol, Collagen Amino Acids, PEG-7M, Carbomer, Dimethicone/Vinyl Dimethicone Crosspolymer, Ethylhexylglycerin, Phospholipids, Silica, Calluna Vulgaris Flower Extract, Glycyrrhethic Acid, Glycyrrhetinic Acid, Hexylene Glycol, Butylene Glycol, Tetrasodium EDTA, Hydrolyzed Rice Protein, Disodium EDTA, Camellia Sinensis Leaf Extract, PVP, Cucumis Sativus (Cucumber) Fruit Extract, Ginkgo Biloba Leaf Extract, Ruscus Aculeatus Root Extract, Echinacea angustifolia extract, Chlorphenesin, Hyaluronic Acid, Polyquaternium-24, Ilex Aquifolium (Holly) Leaf Extract, Sodium Oleanolate, Sodium Ursolate, Ascorbyl Palmitate, Euphrasia Officinalis Extract, Retinyl Palmitate, Diazolidinyl Urea, Yellow 5 (CI 19140), Imidazolidinyl Urea, Palmitoyl Hexapeptide-12, Methylparaben, Red 4 (CI 14700)

Section 51945-4

Section 55105-1

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
Section 55106-9

Active Ingredients (w/w): Purpose

Avobenzone 1.9% .........Sunscreen

Octocrylene 9.4% ......... Sunscreen


Structured Label Content

Indications and Usage (34067-9)

Stop use and ask a doctor if rash occurs.

Dosage and Administration (34068-7)

Directions

For sunscreen use:

apply liberally and evenly 15 minutes before sun exposure

use a water resistant sunscreen if swimming or sweating

reapply at least every 2 hours

children under 6 months: Ask a doctor

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 10 a.m. - 2 p.m.

wear long-sleeved shirts, pants, hats, and sunglasses

Apply to cleansed and toned skin prior to sun exposure

Warnings and Precautions (34071-1)

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.

Section 44425-7 (44425-7)

Other Information

  • protect the product from excessive heat and direct sun
Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

Inactive (non-medicinal) ingredients: Aqua/Water/Eau, Glycerin, Butyloctyl Salicylate, Diethylhexyl Maleate, Jojoba Esters, Cyclopentasiloxane, C10-30 Cholesterol/Lanosterol Esters, Phenyl Trimethicone, Stearic Acid, Stearyl Alcohol, Glyceryl Polymethacrylate, Biosaccharide Gum-1, Sorbitan Stearate, Propylene Glycol, Dimethicone, Dipalmitoyl Hydroxyproline, PEG-100 Stearate, Polysorbate 60, PPG-20 Methyl Glucose Ether, Hydrolyzed Malt Extract, Tocopheryl Acetate, Phenoxyethanol, Bis-Ethylhexyl Hydroxydimethoxy Benzylmalonate, Bisabolol, Cetearyl Methicone, Hydrolyzed Elastin, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, PEG-8, Alcohol, Triethanolamine, Sorbital, Lecithin, Caprylyl Glycol, Collagen Amino Acids, PEG-7M, Carbomer, Dimethicone/Vinyl Dimethicone Crosspolymer, Ethylhexylglycerin, Phospholipids, Silica, Calluna Vulgaris Flower Extract, Glycyrrhethic Acid, Glycyrrhetinic Acid, Hexylene Glycol, Butylene Glycol, Tetrasodium EDTA, Hydrolyzed Rice Protein, Disodium EDTA, Camellia Sinensis Leaf Extract, PVP, Cucumis Sativus (Cucumber) Fruit Extract, Ginkgo Biloba Leaf Extract, Ruscus Aculeatus Root Extract, Echinacea angustifolia extract, Chlorphenesin, Hyaluronic Acid, Polyquaternium-24, Ilex Aquifolium (Holly) Leaf Extract, Sodium Oleanolate, Sodium Ursolate, Ascorbyl Palmitate, Euphrasia Officinalis Extract, Retinyl Palmitate, Diazolidinyl Urea, Yellow 5 (CI 19140), Imidazolidinyl Urea, Palmitoyl Hexapeptide-12, Methylparaben, Red 4 (CI 14700)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

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
Section 55106-9 (55106-9)

Active Ingredients (w/w): Purpose

Avobenzone 1.9% .........Sunscreen

Octocrylene 9.4% ......... Sunscreen


Advanced Ingredient Data


Raw Label Data

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