Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 2bc7861b-03db-42f8-a1a7-cacb65176e42
Route
TOPICAL
Published
Effective Date 2017-12-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (60 mg) Titanium Dioxide (47 mg)
Inactive Ingredients
Water Dimethicone Crosspolymer (450000 Mpa.s At 12% In Cyclopentasiloxane) C12-15 Alkyl Ethylhexanoate Dimethicone Stearic Acid Aluminum Hydroxide Glycerin Cetearyl Olivate Polyglyceryl-4 Isostearate Cetyl Peg/ppg-10/1 Dimethicone (hlb 4) Hexyl Laurate Sodium Chloride Pichia Jadinii Sorbitan Olivate Panthenol Peg-12 Dimethicone/ppg-20 Crosspolymer Caprylyl Glycol Phenoxyethanol Ethylhexylglycerin Hexylene Glycol Hyaluronate Sodium Tocopheryl Nicotinate, D-.alpha.

Identifiers & Packaging

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

Description

ACTIVE INGREDIENTS: Zinc Oxide - 6.0% Titanium Dioxide 4.7%


Medication Information

Indications and Usage

How to use: Apply to your cleansed and toned face and neck every morning as a daily moisturizer. Re-apply every 2 hours when exposed to sun or as needed.

Dosage and Administration

Apply to your cleansed and toned face and neck every morning as a daily moisturizer. Re-apply every 2 hours when exposed to sun or as needed.

Description

ACTIVE INGREDIENTS: Zinc Oxide - 6.0% Titanium Dioxide 4.7%

Section 51727-6

Aqua, Cyclopentasiloxane, C12-15 Alkyl Benzoate, Dimethicone, Cyclohexasiloxane, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Aluminum Hydroxide, Stearic Acid, Glycerin, Cetearyl Olivate,Hexyl Laurate, Sodium Chloride, Pichia/ Resveratrol, Ferment Extract,  Sorbitane Olivate, Dimethicone/Polyglycerin -3 Crosspolymer, Polyglyceryl-4 Isostearate, Panthenol, Cetyl PEG/PPG-10/1 Dimethicone, Triethoxysilylethyl, Polydimethylsiloxyethyl Hexyl Dimethicone, Dimethicone/PEG-10/15 Crosspolymer, Dimethicone/Venyl Dimethicone, Crosspolymer, Sodium Hyaluronate, Phenoxyethanol, Caprylyl Glycol, , Ethylhexylglycerin, Hexylene Glycol, Fragrance, Tocopheryl Acetate.

Section 51945-4

SORELLAAPOTHECARY.COM

Sorella Apothecary, Reno, NV 89509.

Section 55105-1

Purpose: Sunscreen

Section 55106-9

ACTIVE INGREDIENTS:

Zinc Oxide - 6.0%

Titanium Dioxide 4.7%


Structured Label Content

Indications and Usage (34067-9)

How to use: Apply to your cleansed and toned face and neck every morning as a daily moisturizer. Re-apply every 2 hours when exposed to sun or as needed.

Dosage and Administration (34068-7)

Apply to your cleansed and toned face and neck every morning as a daily moisturizer. Re-apply every 2 hours when exposed to sun or as needed.

Section 51727-6 (51727-6)

Aqua, Cyclopentasiloxane, C12-15 Alkyl Benzoate, Dimethicone, Cyclohexasiloxane, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Aluminum Hydroxide, Stearic Acid, Glycerin, Cetearyl Olivate,Hexyl Laurate, Sodium Chloride, Pichia/ Resveratrol, Ferment Extract,  Sorbitane Olivate, Dimethicone/Polyglycerin -3 Crosspolymer, Polyglyceryl-4 Isostearate, Panthenol, Cetyl PEG/PPG-10/1 Dimethicone, Triethoxysilylethyl, Polydimethylsiloxyethyl Hexyl Dimethicone, Dimethicone/PEG-10/15 Crosspolymer, Dimethicone/Venyl Dimethicone, Crosspolymer, Sodium Hyaluronate, Phenoxyethanol, Caprylyl Glycol, , Ethylhexylglycerin, Hexylene Glycol, Fragrance, Tocopheryl Acetate.

Section 51945-4 (51945-4)

SORELLAAPOTHECARY.COM

Sorella Apothecary, Reno, NV 89509.

Section 55105-1 (55105-1)

Purpose: Sunscreen

Section 55106-9 (55106-9)

ACTIVE INGREDIENTS:

Zinc Oxide - 6.0%

Titanium Dioxide 4.7%


Advanced Ingredient Data


Raw Label Data

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