Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 79a3c8e2-c4f2-4c00-8e94-494654ae91a2
Route
TOPICAL
Published
Effective Date 2017-12-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (170 mg)
Inactive Ingredients
Water Cyclomethicone 5 Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone (4000 Mpa.s) Cyclomethicone Peg/ppg-18/18 Dimethicone Alkyl (c12-15) Benzoate Polyisobutylene (1000 Mw) Isododecane Phenoxyethanol Hyaluronate Sodium Caprylyl Glycol .alpha.-tocopherol Acetate Ethylhexylglycerin Hexylene Glycol Mica Aloe Vera Leaf Camellia Sinensis Flower Olea Europaea Leaf Silicon Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-12-04

Description

Zinc Oxide: 17%


Medication Information

Warnings and Precautions

Warnings: For external use only

Indications and Usage

Uses: Help prevent sunburn

Dosage and Administration

Directions: Massage into skin with fingertips and reapply as needed. Avoid eye area while applying.

Description

Zinc Oxide: 17%

Section 50565-1

Keep out of reach of children. if swalloed, get medical help or contact a Poison Control Center right away.

Section 50570-1

Do not use on damged or broken skin.

Section 51727-6

Other Ingredients: Water (Aqua), Cyclopentasiloxane, Dimethicone/PEG10/15 Crosspolymer, Dimethicone/Vinyl Dimethicone Crossploymer, Polyglyceryl-3 polydimethylsiloxyethyl Dimethicone, Cyclomethicone, PEG/PPG-18/18 Dimethicone, Hexyl Triethoxysilylethyl Polydimethylsiloxyethyl Dimethicone, C12-15 Alkyl Benzoate, Polyisobutene, Isododecane, Phenoxyethanol, Sodium Hyaluronate, Caprylyl Glycol, Tocopheryl Acetate, Ethylhexylglycerin, Hexylene Glycol, Mica, Aloe Barbadensis Leaf extract, Camellia Sinensis Leaf Extract, Olea Europaea (Olive) Leaf Extract, Silica

Section 51945-4

Physicians' Aesthetic Research, Inc. Distr.

San Clemente, CA 92672 . Made in U.S.A. www.lucrece.com

Section 55105-1

Purpose:

Suncreen

Section 55106-9

Zinc Oxide: 17%


Structured Label Content

Indications and Usage (34067-9)

Uses: Help prevent sunburn

Dosage and Administration (34068-7)

Directions: Massage into skin with fingertips and reapply as needed. Avoid eye area while applying.

Warnings and Precautions (34071-1)

Warnings: For external use only

Section 50565-1 (50565-1)

Keep out of reach of children. if swalloed, get medical help or contact a Poison Control Center right away.

Section 50570-1 (50570-1)

Do not use on damged or broken skin.

Section 51727-6 (51727-6)

Other Ingredients: Water (Aqua), Cyclopentasiloxane, Dimethicone/PEG10/15 Crosspolymer, Dimethicone/Vinyl Dimethicone Crossploymer, Polyglyceryl-3 polydimethylsiloxyethyl Dimethicone, Cyclomethicone, PEG/PPG-18/18 Dimethicone, Hexyl Triethoxysilylethyl Polydimethylsiloxyethyl Dimethicone, C12-15 Alkyl Benzoate, Polyisobutene, Isododecane, Phenoxyethanol, Sodium Hyaluronate, Caprylyl Glycol, Tocopheryl Acetate, Ethylhexylglycerin, Hexylene Glycol, Mica, Aloe Barbadensis Leaf extract, Camellia Sinensis Leaf Extract, Olea Europaea (Olive) Leaf Extract, Silica

Section 51945-4 (51945-4)

Physicians' Aesthetic Research, Inc. Distr.

San Clemente, CA 92672 . Made in U.S.A. www.lucrece.com

Section 55105-1 (55105-1)

Purpose:

Suncreen

Section 55106-9 (55106-9)

Zinc Oxide: 17%


Advanced Ingredient Data


Raw Label Data

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