DailyMed - SHEER MINERAL ANTIOXIDANT SUNSCREEN SPF50- zinc oxide lotion

NDC Code(s): 51326-144-01
Packager: Topiderm, Inc.

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None

Drug Label Information

Updated March 7, 2025

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SPL UNCLASSIFIED SECTION
Drug Facts

Drug Facts
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Active ingredient
Zinc Oxide 20.5%

Zinc Oxide 20.5%
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Purpose
Sunscreen

Sunscreen
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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.
- 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.
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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 ...
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
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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 ...
- 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.
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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 ...

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.
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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 ...

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

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INGREDIENTS AND APPEARANCE

Product Information

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

Labeler - Topiderm, Inc. (049121643)

Registrant - Topiderm, Inc. (049121643)

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

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

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Label: SHEER MINERAL ANTIOXIDANT SUNSCREEN SPF50- zinc oxide lotion

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Label: SHEER MINERAL ANTIOXIDANT SUNSCREEN SPF50- zinc oxide lotion

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SHEER MINERAL ANTIOXIDANT SUNSCREEN SPF50- zinc oxide lotion

Number of versions: 1

SHEER MINERAL ANTIOXIDANT SUNSCREEN SPF50- zinc oxide lotion

SHEER MINERAL ANTIOXIDANT SUNSCREEN SPF50- zinc oxide lotion

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SHEER MINERAL ANTIOXIDANT SUNSCREEN SPF50- zinc oxide lotion

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