Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID c70a3f80-84a9-4ce7-88a1-4c50d15d758c
Route
TOPICAL
Published
Effective Date 2017-12-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (177 mg)
Inactive Ingredients
Green Tea Leaf White Tea Glycerin Crambe Hispanica Subsp. Abyssinica Seed Oil Medium-chain Triglycerides Raspberry Seed Oil Pomegranate Seed Oil Broccoli Seed Oil Tocopherol N-acetylglucosamine Sweet Cherry Seed Oil Bombyx Mori Fiber Pearl (hyriopsis Cumingii) Hyaluronate Sodium Coffea Arabica Seed, Roasted Lecithin, Soybean Rosemary Oil Xanthan Gum Potassium Sorbate Lavender Oil Phenylethyl Alcohol Ethylhexylglycerin Ferric Oxide Red Ferric Oxide Yellow Ferrosoferric Oxide Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-12-15

Description

Non Nano Zinc Oxide - 17.7%


Medication Information

Warnings and Precautions

for external use only. if irritation developes, discontinue use and consult physician.

Indications and Usage

Uses: if used as directed with other sun protection measures, this product reduces the risk of cancer, early skin aging and helps prevent sunburn.

Dosage and Administration

Shake well and keep in a cool place. Apply liberally to face, neck and chest before sun exposure. Reapply as needed, and after swimming, perspirin or towel drying. For children under 6 months, consult physicain.

Description

Non Nano Zinc Oxide - 17.7%

Section 51727-6

Camellia Sinensis (Green and White Tea) Leaf Extract, Glycerin, Crambe Abyssinica (Abyssinian Seed Oil, Caprylic/Capric Triglycerides (from Coconut), Rubus Idaeus (Red Raspberry) Seed Oil, Punica Granatum (Pomegranade) Seed Oil, Brassica Oleracea Italic (Broccoli) Seed Oil, Tocoperol (non-GMO Vitamin E), Acetyl Glucosamine ( from non-GMO corn), Prunus Avium (Sweet Cherry Seed Oil), Silk Powder, Pearl Powder, Sodium Hyaluronate (Hyaluronic Acid), Beta-Glucan, Coffea Arabica (Coffee) Seed Extract, Lecithin, Rosemary Officinalis (Rosemary) Leaf Extract, Xanthan Gum, Potassium Sorbate, Citrus Aurantium Amara (Neroli) FLower Oil, Lavandula Angustifolia (Lavender) Oil, Phenethyl Alcohol, Ethylhexylglycerin, Iron Oxides, Mica, Titanium Dioxide (For Pigment).

Section 51945-4

True Botanicals

Mill Valley, California 94941

truebotanicals.com

Section 55105-1

Sunscreen

Section 55106-9

Non Nano Zinc Oxide - 17.7%


Structured Label Content

Indications and Usage (34067-9)

Uses: if used as directed with other sun protection measures, this product reduces the risk of cancer, early skin aging and helps prevent sunburn.

Dosage and Administration (34068-7)

Shake well and keep in a cool place. Apply liberally to face, neck and chest before sun exposure. Reapply as needed, and after swimming, perspirin or towel drying. For children under 6 months, consult physicain.

Warnings and Precautions (34071-1)

for external use only. if irritation developes, discontinue use and consult physician.

Section 51727-6 (51727-6)

Camellia Sinensis (Green and White Tea) Leaf Extract, Glycerin, Crambe Abyssinica (Abyssinian Seed Oil, Caprylic/Capric Triglycerides (from Coconut), Rubus Idaeus (Red Raspberry) Seed Oil, Punica Granatum (Pomegranade) Seed Oil, Brassica Oleracea Italic (Broccoli) Seed Oil, Tocoperol (non-GMO Vitamin E), Acetyl Glucosamine ( from non-GMO corn), Prunus Avium (Sweet Cherry Seed Oil), Silk Powder, Pearl Powder, Sodium Hyaluronate (Hyaluronic Acid), Beta-Glucan, Coffea Arabica (Coffee) Seed Extract, Lecithin, Rosemary Officinalis (Rosemary) Leaf Extract, Xanthan Gum, Potassium Sorbate, Citrus Aurantium Amara (Neroli) FLower Oil, Lavandula Angustifolia (Lavender) Oil, Phenethyl Alcohol, Ethylhexylglycerin, Iron Oxides, Mica, Titanium Dioxide (For Pigment).

Section 51945-4 (51945-4)

True Botanicals

Mill Valley, California 94941

truebotanicals.com

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Non Nano Zinc Oxide - 17.7%


Advanced Ingredient Data


Raw Label Data

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