sage pharmaceuticals inc

sage pharmaceuticals inc
SPL v32919
SPL
SPL Set ID 3757df59-2560-45dc-ba3b-d88fe0956118
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 dimethicone silicon dioxide trehalose propanediol sodium acrylates crosspolymer-2 1,2-hexanediol xanthan gum butylene glycol lecithin, sunflower disodium glycyrrhizate caprylhydroxamic acid medicago sativa whole

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2022-11-28

Purpose

Sunscreen

Description

Titanium Dioxide   11.3%


Medication Information

Uses

HVA / UVB protection

  • Tear-free formula
  • Paraben free
  • Hypoallergenic
  • Fragrance free
Purpose

Sunscreen

Directions

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

Inactive Ingredients

WATER, TRISILOXANE, PEG-6 CAPRYLIC/CAPRIC GLYCERIDES, COCO-CAPRYLATE/CAPRATE, GLYCERYL STEARATE CITRATE, PENTYLENE GLYCOL,

DIMETHICONE, SILICON DIOXIDE, TREHALOSE, PROPANEDIOL, SODIUM ACRYLATES CROSSPOLYMER-2, 1,2-HEXANEDIOL, XANTHAN GUM, BUTYLENE GLYCOL, LECITHIN, SUNFLOWER, DISODIUM GLYCYRRHIZATE, CAPRYLHYDROXAMIC ACID, MEDICAGO SATIVA WHOLE

Description

Titanium Dioxide   11.3%

Section 42229-5

Sage Pharmaceuticals Inc

Product of Taiwan

Manufactured for IDAQS Biotech, Inc.

Distributed by Beauty River International Inc.

901 S. Fremont Ave 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

Active Ingredients

Titanium Dioxide   11.3%


Structured Label Content

Uses

HVA / UVB protection

  • Tear-free formula
  • Paraben free
  • Hypoallergenic
  • Fragrance free
Purpose

Sunscreen

Directions

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

Inactive Ingredients

WATER, TRISILOXANE, PEG-6 CAPRYLIC/CAPRIC GLYCERIDES, COCO-CAPRYLATE/CAPRATE, GLYCERYL STEARATE CITRATE, PENTYLENE GLYCOL,

DIMETHICONE, SILICON DIOXIDE, TREHALOSE, PROPANEDIOL, SODIUM ACRYLATES CROSSPOLYMER-2, 1,2-HEXANEDIOL, XANTHAN GUM, BUTYLENE GLYCOL, LECITHIN, SUNFLOWER, DISODIUM GLYCYRRHIZATE, CAPRYLHYDROXAMIC ACID, MEDICAGO SATIVA WHOLE

Section 42229-5 (42229-5)

Sage Pharmaceuticals Inc

Product of Taiwan

Manufactured for IDAQS Biotech, Inc.

Distributed by Beauty River International Inc.

901 S. Fremont Ave 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)

Storage

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

Cautions

External use only

Active Ingredients

Titanium Dioxide   11.3%


Advanced Ingredient Data


Raw Label Data

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