SHEER MINERAL ANTIOXIDANT SUNSCREEN SPF50- zinc oxide lotion

Sheer Mineral Antioxidant Sunscreen by

Drug Labeling and Warnings

Sheer Mineral Antioxidant Sunscreen by is a Otc medication manufactured, distributed, or labeled by Topiderm, Inc., Topix Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Zinc Oxide 20.5%

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 10a.m.-2 p.m.
• wear long-sleeve shirts, pants, hats, and sunglasses

Directions

• Apply liberally and spread evenly by hand 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

Acrylates Crosspolymer-4, Ascorbic Acid, Ascorbyl Palmitate, Biotin, C12-15 Alkyl Benzoate, C13-15 Alkane, Camellia Sinensis (Green Tea) Polyphenols, Cetearyl Alcohol, Ceteth-10 Phosphate, Dicetyl Phosphate, Disodium EDTA, Isostearic Acid, Lauryl PEG/PPG-18/18 Methicone, Phenoxyethanol, Phospholipids, Phyllanthus Emblica Fruit Extract, Polyhydroxystearic Acid, Potassium Cetyl Phosphate, Potassium Hydroxide, Purified Water, Resveratrol, Retinyl Palmitate, Tocopheryl Acetate, Triethoxycaprylylsilane, Ubiquinone, Xanthan Gum.

PRINCIPAL DISPLAY PANEL - 57 g Container Label

COMPLIMENTS OF

TOPIX
PHARMACEUTICALS, INC

DAILY

Sheer Mineral
Antioxidant
Sunscreen SPF 50

Broad Spectrum SPF 50

Net wt. 2 oz. (57 g)

Available
Custom Branded
800.445.2595
c.service@topixpharm.com

INGREDIENTS AND APPEARANCE

SHEER MINERAL ANTIOXIDANT SUNSCREEN  SPF50
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51326-144
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	205 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ACRYLATES CROSSPOLYMER-4 (UNII: GEV2EL4D9G)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BIOTIN (UNII: 6SO6U10H04)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
C13-15 ALKANE (UNII: 114P5I43UJ)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ISOSTEARIC ACID (UNII: X33R8U0062)
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
WATER (UNII: 059QF0KO0R)
RESVERATROL (UNII: Q369O8926L)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
UBIDECARENONE (UNII: EJ27X76M46)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51326-144-01	57 g in 1 CONTAINER; Type 0: Not a Combination Product	04/25/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M020	04/25/2024

Labeler - Topiderm, Inc. (049121643)

Registrant - Topiderm, Inc. (049121643)

Establishment
Name	Address	ID/FEI	Business Operations
Topiderm, Inc.		049121643	MANUFACTURE(51326-144)

Establishment
Name	Address	ID/FEI	Business Operations
Topix Pharmaceuticals, Inc.		117745066	PACK(51326-144)