Rosease

Rosease
SPL v3
SPL
SPL Set ID c9e1afe1-4b1d-42d0-a1fe-b554adeaf811
Route
TOPICAL
Published
Effective Date 2022-05-25
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 Vinylpyrrolidone/eicosene Copolymer Carthamus Tinctorius Seed Oleosomes Cardamom Aloe Vera Leaf .alpha.-tocopherol Acetate Perilla Frutescens Leaf Apple Rosa Centifolia Flower Sandalwood Green Tea Leaf Chamaemelum Nobile Flower Cananga Odorata Flower Orange Peel Muskmelon Cucumber Jasminum Officinale Flower Lavandula Angustifolia Subsp. Angustifolia Flowering Top Raspberry Polygonum Aviculare Top Vitis Vinifera High Tannin Cultivar Fruit Cell Lysate Propanediol Cetostearyl Alcohol Pentylene Glycol Arachidyl Alcohol Polyhydroxystearic Acid (2300 Mw) 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 DRUG Active Since 2022-05-25

Description

Octinoxate 7.5% Zinc Oxide 10.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Octinoxate 7.5% Zinc Oxide 10.0%

Uses:

Helps prevent sunburn.

Section 42229-5

ENRICHED WITH BOTANICAL EXTRACTS

EXCELLENT SKIN TOLERANCE

FREE RADICAL PROTECTION

For All Skin Types

8

DERMATOLOGICALLY TESTED

TENDER LOVING CARE

NON-IRRITATING

THE ROSEASE TOOLKIT

Distributed by:

Anna Lotan USA Inc.

16 Wheeling Ave.

Woburn, MA 01801

www .annalotanusa.com

Section 50565-1

Keep out of reach of children.

Packaging

Warnings:

For external use only.

Do not useon damaged or broken skin.

When using this productkeep out of eyes. Rinse with water to remove.

Stop use and ask a doctorif 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 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 sun from 10 a.m.- 2 p.m.

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

Drug Facts:

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, cocoglucoside, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, behenyl alcohol, xanthan gum, triethoxycaprylylsilane, arachidyl glucoside, phenethyl alcohol, caprylyl glycol.

Questions Or Comments?

(781) 281-0954


Structured Label Content

Uses: (USES:)

Helps prevent sunburn.

Section 42229-5 (42229-5)

ENRICHED WITH BOTANICAL EXTRACTS

EXCELLENT SKIN TOLERANCE

FREE RADICAL PROTECTION

For All Skin Types

8

DERMATOLOGICALLY TESTED

TENDER LOVING CARE

NON-IRRITATING

THE ROSEASE TOOLKIT

Distributed by:

Anna Lotan USA Inc.

16 Wheeling Ave.

Woburn, MA 01801

www .annalotanusa.com

Section 50565-1 (50565-1)

Keep out of reach of children.

Purpose

Sunscreen

Packaging

Warnings: (WARNINGS:)

For external use only.

Do not useon damaged or broken skin.

When using this productkeep out of eyes. Rinse with water to remove.

Stop use and ask a doctorif 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 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 sun from 10 a.m.- 2 p.m.

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

Drug Facts: (DRUG FACTS:)

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, cocoglucoside, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, behenyl alcohol, xanthan gum, triethoxycaprylylsilane, arachidyl glucoside, phenethyl alcohol, caprylyl glycol.

Questions Or Comments? (QUESTIONS OR COMMENTS?)

(781) 281-0954


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