SPL v1
SPL
SPL Set ID f43b7112-1034-460f-bcca-7a3b4f325315
Route
TOPICAL
Published
Effective Date 2021-12-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (11.51 g) Zinc Cation (4.75 g) .alpha.-bisabolol, (+/-)- (0.5 g)
Inactive Ingredients
Water Isoamyl Laurate Medium-chain Triglycerides

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2021-12-01

Description

Titanium Dioxide 11.51% Zinc Oxide 4.75% .ALPHA.-BISABOLOL, (+/-)- 0.5%

Purpose

Sunscreen, Brightening


Medication Information

Purpose

Sunscreen, Brightening

Description

Titanium Dioxide 11.51% Zinc Oxide 4.75% .ALPHA.-BISABOLOL, (+/-)- 0.5%

Uses

Helps to keep the bright skin tone with excellent coverage.

Warnings

For external use only.

In case of having side effects such as red rash, swollenness and/or itching while using this cosmetic consult a dermatologist immediately.

Keep out of reach of children.

Questions

www.rootsallo.com 82-31-429-0588

Directions

Using puff applicator, press down lightly onto pre-saturated cushion sponge to capture product and pat evenly over face.

Other Information

Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light.

Active Ingredients

Titanium Dioxide 11.51%

Zinc Oxide 4.75%

.ALPHA.-BISABOLOL, (+/-)- 0.5%

Inactive Ingredients

Water, Isoamyl Laurate, Caprylic/Capric Triglyceride, Oenothera Biennis (Evening Primrose) Oil, Macadamia Integrifolia Seed Oil, Polyglyceryl-3 Polyricinoleate, Sorbitan Olivate, Glycerin, Sodium Chloride, Scutellaria Baicalensis Root Extract, Hydrogenated Olive Oil, Propanediol, Glyceryl Caprylate, Lauroyl Lysine, Betaine, Chamaecyparis Obtusa Oil, Olea Europaea (Olive) Fruit Oil, Aluminum Hydroxide, Citric Acid, Magnesium Stearate, Iron Oxide Red, Arginine, Stearic Acid, p-Anisic Acid, Tocopherol, Iron Oxide Black, Olea Europaea (Olive) Oil Unsaponifiables, Mica, Sodium Hyaluronate, Magnesium Palmitate, Centella Asiatica Extract, Aloe Barbadensis Leaf Extract, Polygonum Cuspidatum Root Extract, Camellia Sinensis Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Bioflavonoids, Brassica Oleracea Italica (Broccoli) Extract, *Limonene (essential oil component)

Keep Out of Reach of Children

KEEP OUT OF REACH OF CHILDREN

Package Label.principal Display Panel


Structured Label Content

Uses

Helps to keep the bright skin tone with excellent coverage.

Purpose (PURPOSE)

Sunscreen, Brightening

Warnings

For external use only.

In case of having side effects such as red rash, swollenness and/or itching while using this cosmetic consult a dermatologist immediately.

Keep out of reach of children.

Questions

www.rootsallo.com 82-31-429-0588

Directions

Using puff applicator, press down lightly onto pre-saturated cushion sponge to capture product and pat evenly over face.

Other Information

Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light.

Active Ingredients (ACTIVE INGREDIENTS)

Titanium Dioxide 11.51%

Zinc Oxide 4.75%

.ALPHA.-BISABOLOL, (+/-)- 0.5%

Inactive Ingredients (Inactive ingredients)

Water, Isoamyl Laurate, Caprylic/Capric Triglyceride, Oenothera Biennis (Evening Primrose) Oil, Macadamia Integrifolia Seed Oil, Polyglyceryl-3 Polyricinoleate, Sorbitan Olivate, Glycerin, Sodium Chloride, Scutellaria Baicalensis Root Extract, Hydrogenated Olive Oil, Propanediol, Glyceryl Caprylate, Lauroyl Lysine, Betaine, Chamaecyparis Obtusa Oil, Olea Europaea (Olive) Fruit Oil, Aluminum Hydroxide, Citric Acid, Magnesium Stearate, Iron Oxide Red, Arginine, Stearic Acid, p-Anisic Acid, Tocopherol, Iron Oxide Black, Olea Europaea (Olive) Oil Unsaponifiables, Mica, Sodium Hyaluronate, Magnesium Palmitate, Centella Asiatica Extract, Aloe Barbadensis Leaf Extract, Polygonum Cuspidatum Root Extract, Camellia Sinensis Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Bioflavonoids, Brassica Oleracea Italica (Broccoli) Extract, *Limonene (essential oil component)

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

KEEP OUT OF REACH OF CHILDREN

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

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