ESSENTIAL SHEER SPF 50- zinc oxide titanium dioxide lotion

Essential Sheer by

Drug Labeling and Warnings

Essential Sheer by is a Otc medication manufactured, distributed, or labeled by Topiderm, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Zinc Oxide 14.5%

Octinoxate 7.5%

Purpose

Sunscreen

Uses

• Helps prevent sunburn
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only.

When using this product keep out of eyes, rinse with water to remove.

Stop use if signs of irritation or rash appear. If irritation or rash persists consult a doctor.

Keep out of reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Sun Protection Measures.

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sunscreen measures including:

• limit time in the sun, especially from 10 a.m.-2 p.m.
• wear long-sleeve shirts, pants, hats, and sunglasses

Directions

• Apply liberally to face and neck and spread evenly 15 minutes before sun exposure
• Re-apply after swimming, excessive perspiring, or anytime after towel drying
• Use a water resistant sunscreen if swimming or sweating
• Use on children under 6 months of age: consult a doctor.

Inactive ingredients

Purified Water, Niacinamide, Oleth-3 Phosphate, Neopentyl Glycol Diheptanoate, Polyisobutene, Octyldodecyl, Neopentanoate, Butylene Glycol, Tocopheryl Acetate, Sodium Hyaluronate, Caffeine, Panthenol, Dimethicone, Sucrose, Lactic Acid, Glycerin, Ethylhexyl Stearate, Triethoxycaprylylsilan, Xanthan Gum, Lauryl PEG Polydimethylsiloxyethyl Dimethicone, PEG-7 Trimethylolpropane Coconut Ether, Hydroxyethyl Acrylate/Sodium Acryloydimethyl Taurate Copolymer, Phenoxyethanol, Disodium EDTA.

PRINCIPAL DISPLAY PANEL - 63 g Bottle Label

COMPLIMENTS OF
TOPIX
PHARMACEUTICALS, INC

DAILY

Sheer Lightweight
Brightening
Sunscreen SPF 50

Broad Spectrum
SPF 50 Sunscreen

FOR PATIENTS WITH ACNE,
ROSACEA PRONE AND
HYPERPIGMENTED SKIN

Net wt. 2.22 oz. (63 g)

Available
Custom Branded
800.445.2595
c.service@topixpharm.com

INGREDIENTS AND APPEARANCE

ESSENTIAL SHEER   SPF 50
zinc oxide titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51326-200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	145 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	75 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
NIACINAMIDE (UNII: 25X51I8RD4)
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
HYDROGENATED POLYISOBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CAFFEINE (UNII: 3G6A5W338E)
PANTHENOL (UNII: WV9CM0O67Z)
DIMETHICONE (UNII: 92RU3N3Y1O)
SUCROSE (UNII: C151H8M554)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
GLYCERIN (UNII: PDC6A3C0OX)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
XANTHAN GUM (UNII: TTV12P4NEE)
PEG-7 TRIMETHYLOLPROPANE COCONUT ETHER (UNII: MVJ3AD73GG)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51326-200-01	63 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/29/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M020	07/29/2019

Labeler - Topiderm, Inc. (049121643)

Registrant - Topiderm, Inc. (049121643)

Establishment
Name	Address	ID/FEI	Business Operations
Topiderm, Inc.		049121643	MANUFACTURE(51326-200)