Sage Pharmaceuticals Inc

Sage Pharmaceuticals Inc
SPL v32920
SPL
SPL Set ID bc1e070f-86b8-4b6b-aec8-ed2fc6008ef1
Route
TOPICAL
Published
Effective Date 2024-12-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (11.3 g)
Inactive Ingredients
Water Trisiloxane Peg-6 Caprylic/capric Glycerides Coco-caprylate/caprate Glyceryl Stearate Citrate Pentylene Glycol N-acetylglucosamine Niacinamide Dimethicone Silicon Dioxide Propanediol Sodium Acrylates Crosspolymer-2 1,2-hexanediol Xanthan Gum Butylene Glycol Lecithin, Sunflower Caprylhydroxamic Acid Medicago Sativa Whole

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-11-28

Description

Titanium Dioxide   11.3%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide   11.3%

Uses

UVA / UVB / HEV protection

Section 42229-5

Sage Pharmaceuticals, Inc

Product of Taiwan

Distributed by

Beauty River International Group, Inc

901 S. Fremont Ave Suite 108,

Alhambra, CA 91803-4703, USA

Section 50565-1

Keep out of reach of children.

Section 50566-9

Avoid contact with eyes. In case of severe irritation, stop usage immediately and consult a doctor.

Section 51945-4

Storage

Store in a cool, dry place away from heat and direct sunlight.

Cautions

External use only

Directions

Apply an appropriate amount to the face and body prior to sun exposure, then pat lightly on the area. Reapply as needed.

Active Ingredients

Titanium Dioxide   11.3%

Inactive Ingredients

WATER, TRISILOXANE, PEG-6 CAPRYLIC/CAPRIC GLYCERIDES, COCO-CAPRYLATE/CAPRATE, GLYCERYL STEARATE CITRATE, PENTYLENE GLYCOL,  N-ACETYLGLUCOSAMINE, NIACINAMIDE, DIMETHICONE, SILICON DIOXIDE, PROPANEDIOL, SODIUM ACRYLATES CROSSPOLYMER-2, 1,2-HEXANEDIOL, XANTHAN GUM, BUTYLENE GLYCOL, LECITHIN, SUNFLOWER, CAPRYLHYDROXAMIC ACID, MEDICAGO SATIVA WHOLE


Structured Label Content

Uses

UVA / UVB / HEV protection

Section 42229-5 (42229-5)

Sage Pharmaceuticals, Inc

Product of Taiwan

Distributed by

Beauty River International Group, Inc

901 S. Fremont Ave Suite 108,

Alhambra, CA 91803-4703, USA

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Avoid contact with eyes. In case of severe irritation, stop usage immediately and consult a doctor.

Section 51945-4 (51945-4)

Purpose

Sunscreen

Storage

Store in a cool, dry place away from heat and direct sunlight.

Cautions

External use only

Directions

Apply an appropriate amount to the face and body prior to sun exposure, then pat lightly on the area. Reapply as needed.

Active Ingredients

Titanium Dioxide   11.3%

Inactive Ingredients

WATER, TRISILOXANE, PEG-6 CAPRYLIC/CAPRIC GLYCERIDES, COCO-CAPRYLATE/CAPRATE, GLYCERYL STEARATE CITRATE, PENTYLENE GLYCOL,  N-ACETYLGLUCOSAMINE, NIACINAMIDE, DIMETHICONE, SILICON DIOXIDE, PROPANEDIOL, SODIUM ACRYLATES CROSSPOLYMER-2, 1,2-HEXANEDIOL, XANTHAN GUM, BUTYLENE GLYCOL, LECITHIN, SUNFLOWER, CAPRYLHYDROXAMIC ACID, MEDICAGO SATIVA WHOLE


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)