SPL v1
SPL
SPL Set ID 2d40099a-2cfa-1d99-e063-6394a90a36a6
Route
TOPICAL
Published
Effective Date 2020-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (90 mg)
Inactive Ingredients
Tetrahexyldecyl Ascorbate Peg-10 Dimethicone (600 Cst) Sambucus Nigra Flower Dimethiconol (2000 Cst) Polysorbate 20 Saccharomyces Cerevisiae Caprylhydroxamic Acid Alpha-tocopherol Acetate Palmitoyl Tetrapeptide-7 Glycerin Isohexadecane Palmitoyl Tripeptide-1 Silanetriol Lauryl Peg/ppg-18/18 Methicone Butylene Glycol Corallina Officinalis Dimethicone Crosspolymer Water Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Hydrogen Dimethicone (20 Cst) Isododecane Cyclohexasiloxane Cyclopentasiloxane Carbomer Caprylyl Glycol Caffeine Undaria Pinnatifida

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-09-01

Description

Zinc Oxide 9%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 9%

Section 51727-6

Butylene Glycol, Caffeine, Carbomer, Caprylhydroxamic Acid, Caprylyl Glycol, Corallina Officinalis Extract, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Glycerin, Hydrogen Dimethicone, Isododecane, Isohexadecane, Lauryl PEG/PPG-18/18 Methicone, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, PEG-10 Dimethicone, Polysorbate 20, Saccharomyces/Selenium Ferment, Sambucus Nigra Flower Extract, Siloxanetriol Alginate, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Undaria Pinnatifida Extract, Water

Section 51945-4

Purpose:

Sunscreen

Warning:

For external use only. Keep out of the reach of children.

Directions:

Apply liberally 15 minutes before sun exposure.

Active Ingredient:

Zinc Oxide 9%

Warning and Directions:

For external use only. Keep out of the reach of children. Apply liberally 15 minutes before sun exposure.


Structured Label Content

Section 51727-6 (51727-6)

Butylene Glycol, Caffeine, Carbomer, Caprylhydroxamic Acid, Caprylyl Glycol, Corallina Officinalis Extract, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Glycerin, Hydrogen Dimethicone, Isododecane, Isohexadecane, Lauryl PEG/PPG-18/18 Methicone, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, PEG-10 Dimethicone, Polysorbate 20, Saccharomyces/Selenium Ferment, Sambucus Nigra Flower Extract, Siloxanetriol Alginate, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Undaria Pinnatifida Extract, Water

Section 51945-4 (51945-4)

Purpose:

Sunscreen

Warning:

For external use only. Keep out of the reach of children.

Directions:

Apply liberally 15 minutes before sun exposure.

Active Ingredient:

Zinc Oxide 9%

Warning and Directions:

For external use only. Keep out of the reach of children. Apply liberally 15 minutes before sun exposure.


Advanced Ingredient Data


Raw Label Data

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