Caragala - Botanical Defense Day Cream Broad Spectrum Spf 30 Sunscreen

Caragala - Botanical Defense Day Cream Broad Spectrum Spf 30 Sunscreen
SPL v1
SPL
SPL Set ID 9000fa5a-3c8a-479b-95e8-2abfdabb544f
Route
TOPICAL
Published
Effective Date 2022-03-08
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 2022-04-01

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 each of children.

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

Section 50566-9

Stop use and ask a doctor if rash occurs.

Section 50567-7

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

Section 50570-1

Do not use on damaged or broken skin.

Warnings

For external use only.

Directions

Apply to all skin exposed to the sun. Apply liberally and evenly 15 minutes before sun exposure. Reapply at least every 2 hours. If swimming or sweating, use water resistant sunscreen.

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. Decrease this risk, by regularly using sunscreen with a Broad Spectrum SPF 15 or higher and other sun protection measures including:

  • limit time in the sun, especially from 10 am - 2 pm
  • wear long-sleeved shirts, pants, hats, and sunglasses

Children under 6 months: Ask a doctor

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, ArachidylAlcohol, PolyhydroxystearicAcid, Coco-Glucoside, HydroxyethylAcrylate/Sodium Acryloyldimethyl Taurate Copolymer, Behenyl Alcohol, Xanthan Gum, Triethoxycaprylylsilane, Arachidyl Glucoside, PhenethylAlcohol, Caprylyl Glycol.

Principal Display Panel 60 G Tube Carton

Cara Gala

Botanical

Defense

Day Cream

Broad Spectrum

SPF 30

Sunscreen

SUNSCREEN

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 each of children.

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs.

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

Do not use on damaged or broken skin.

Purpose

Sunscreen

Warnings (WARNINGS)

For external use only.

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. If swimming or sweating, use water resistant sunscreen.

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. Decrease this risk, by regularly using sunscreen with a Broad Spectrum SPF 15 or higher and other sun protection measures including:

  • limit time in the sun, especially from 10 am - 2 pm
  • wear long-sleeved shirts, pants, hats, and sunglasses

Children under 6 months: Ask a doctor

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, ArachidylAlcohol, PolyhydroxystearicAcid, Coco-Glucoside, HydroxyethylAcrylate/Sodium Acryloyldimethyl Taurate Copolymer, Behenyl Alcohol, Xanthan Gum, Triethoxycaprylylsilane, Arachidyl Glucoside, PhenethylAlcohol, Caprylyl Glycol.

Principal Display Panel 60 G Tube Carton (PRINCIPAL DISPLAY PANEL - 60 G Tube Carton)

Cara Gala

Botanical

Defense

Day Cream

Broad Spectrum

SPF 30

Sunscreen

SUNSCREEN

NET WT. 2 OZ. (60G)


Advanced Ingredient Data


Raw Label Data

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