UNID PHYSICAL SUN- titanium dioxide lotion

UNID Physical Sun by

Drug Labeling and Warnings

UNID Physical Sun by is a Otc medication manufactured, distributed, or labeled by Sage Pharmaceuticals Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Titanium Dioxide   11.3%

Purpose

Sunscreen

Uses

HVA / UVB protection

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

Directions

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

Cautions

External use only

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

STOP USE

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

Storage

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

SPL UNCLASSIFIED SECTION

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

UNID PHYSICAL SUN 
titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83119-243
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	11.3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
TRISILOXANE (UNII: 9G1ZW13R0G)
PEG-6 CAPRYLIC/CAPRIC GLYCERIDES (UNII: GO50W2HWO8)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TREHALOSE (UNII: B8WCK70T7I)
PROPANEDIOL (UNII: 5965N8W85T)
SODIUM ACRYLATES CROSSPOLYMER-2 (UNII: D3HPR4WW6F)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
XANTHAN GUM (UNII: TTV12P4NEE)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
DISODIUM GLYCYRRHIZATE (UNII: L8Q0US0J7V)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
MEDICAGO SATIVA WHOLE (UNII: DJO934BRBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83119-243-50	1 in 1 PACKAGE	11/28/2022
1		50 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020.10	11/28/2022

Labeler - Sage Pharmaceuticals Inc (656245476)

Registrant - Sage Pharmaceuticals Inc (656245476)

Establishment
Name	Address	ID/FEI	Business Operations
Sage Pharmaceuticals Inc		656245476	manufacture(83119-243)