Professional Solutions®

Professional Solutions®
SPL v2
SPL
SPL Set ID b32ad6f1-5953-47b6-b488-5cce6a20895e
Route
TOPICAL
Published
Effective Date 2023-01-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (7.5 g) Zinc Oxide (10 g)
Inactive Ingredients
Water Butyloctyl Salicylate Glycerin Dimethicone Styrene/acrylamide Copolymer (500000 Mw) Cocoyl Caprylocaprate Medium-chain Triglycerides Carthamus Tinctorius Seed Oleosomes Cardamom Aloe Vera Leaf .alpha.-tocopherol Acetate Perilla Frutescens Seed Apple Santalum Album Seed Green Tea Leaf Chamaemelum Nobile Flower Cananga Odorata Flower Orange Peel Muskmelon Jasminum Officinale Flower Lavandula Angustifolia Subsp. Angustifolia Flowering Top Raspberry Polygonum Aviculare Top Propanediol Cetostearyl Alcohol Pentylene Glycol Arachidyl Alcohol Coco Glucoside Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) Docosanol Xanthan Gum Triethoxycaprylylsilane Arachidyl Glucoside Phenylethyl Alcohol Caprylyl Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-01

Description

DRUG FACTS:

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

DRUG FACTS:

Uses

Helps prevent sunburn.

Section 42229-5

DRUG FACTS:

Section 50565-1

Keep out of reach of children.

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. Stop use and ask a doctor if rash occurs.

Directions

Apply to all skin exposed to the sun. *Apply liberally and evenly 15 minutes before sun exposure.*Reapply at least every 2 hours. *Use a water-resistant sunscreen if swimming or sweating. *For children under 6 months of age: 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.
Other Information

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

Active Ingredients

Octinoxate 7.5%, Zinc Oxide 10.0%.

Inactive Ingredients

Water (Aqua), Butyloctyl Salicylate, Glycerin, Dimethicone, Styrene/Acrylates Copolymer, Coco-Caprylate/Caprate, Caprylic/Capric Triglyceride, VP/Eicosene Copolymer, Carthamus Tinctorius Oleosomes, Elettaria Cardamomum Seed Extract, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Perilla Frutescens Extract, Pyrus Malus (Apple) Fruit Extract, Rose Extract, Santalum Album Extract, Camellia Sinensis Leaf Extract, Anthemis Nobilis Flower Extract, Cananga Odorata Flower Extract, Citrus Aurantium Dulcis (Orange) Peel Extract, Cucumis Melo (Melon) Fruit Extract, Cucumis Sativus Fruit Extract, Jasminum Officinale Flower/Leaf Extract, Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, Rubus Idaeus (Raspberry) Fruit Extract, Polygonum Aviculare Extract, Vitis Vinifera Fruit Cell Extract, Propanediol, Cetearyl Alcohol, Pentylene Glycol, Arachidyl Alcohol, Polyhydroxystearic Acid, Coco-Glucoside, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Behenyl Alcohol, Xanthan Gum, Triethoxycaprylylsilane, Arachidyl Glucoside, Phenethyl Alcohol, Caprylyl Glycol.

Principal Display Panel 60 G Jar Label

Professional

Solutions®

PURE SCIENCE. BETTER SKIN

daily defense

moisturizer

broad spectrum

spf 30 sunscreen

moisturizes +

net WT. 2 Oz. (60g)


Structured Label Content

Uses (USES)

Helps prevent sunburn.

Section 42229-5 (42229-5)

DRUG FACTS:

Section 50565-1 (50565-1)

Keep out of reach of children.

Purpose

Sunscreen

Warnings (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. Stop use and ask a doctor if rash occurs.

Directions (DIRECTIONS)

Apply to all skin exposed to the sun. *Apply liberally and evenly 15 minutes before sun exposure.*Reapply at least every 2 hours. *Use a water-resistant sunscreen if swimming or sweating. *For children under 6 months of age: 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.
Other Information (OTHER INFORMATION)

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

Active Ingredients (ACTIVE INGREDIENTS)

Octinoxate 7.5%, Zinc Oxide 10.0%.

Inactive Ingredients (INACTIVE INGREDIENTS)

Water (Aqua), Butyloctyl Salicylate, Glycerin, Dimethicone, Styrene/Acrylates Copolymer, Coco-Caprylate/Caprate, Caprylic/Capric Triglyceride, VP/Eicosene Copolymer, Carthamus Tinctorius Oleosomes, Elettaria Cardamomum Seed Extract, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Perilla Frutescens Extract, Pyrus Malus (Apple) Fruit Extract, Rose Extract, Santalum Album Extract, Camellia Sinensis Leaf Extract, Anthemis Nobilis Flower Extract, Cananga Odorata Flower Extract, Citrus Aurantium Dulcis (Orange) Peel Extract, Cucumis Melo (Melon) Fruit Extract, Cucumis Sativus Fruit Extract, Jasminum Officinale Flower/Leaf Extract, Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, Rubus Idaeus (Raspberry) Fruit Extract, Polygonum Aviculare Extract, Vitis Vinifera Fruit Cell Extract, Propanediol, Cetearyl Alcohol, Pentylene Glycol, Arachidyl Alcohol, Polyhydroxystearic Acid, Coco-Glucoside, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Behenyl Alcohol, Xanthan Gum, Triethoxycaprylylsilane, Arachidyl Glucoside, Phenethyl Alcohol, Caprylyl Glycol.

Principal Display Panel 60 G Jar Label (PRINCIPAL DISPLAY PANEL - 60 g Jar Label)

Professional

Solutions®

PURE SCIENCE. BETTER SKIN

daily defense

moisturizer

broad spectrum

spf 30 sunscreen

moisturizes +

net WT. 2 Oz. (60g)


Advanced Ingredient Data


Raw Label Data

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