Essential Sheer

Essential Sheer
SPL v1
SPL
SPL Set ID 2132dc18-85ee-4449-86d2-d9f698f286c6
Route
TOPICAL
Published
Effective Date 2024-07-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (145 mg) Titanium Dioxide (75 mg)
Inactive Ingredients
Water Niacinamide Oleth-3 Phosphate Neopentyl Glycol Diheptanoate Hydrogenated Polyisobutene (1300 Mw) Octyldodecyl Neopentanoate Butylene Glycol .alpha.-tocopherol Acetate Hyaluronate Sodium Caffeine Panthenol Dimethicone Sucrose Lactic Acid, Unspecified Form Glycerin Ethylhexyl Stearate Triethoxycaprylylsilane Xanthan Gum Peg-7 Trimethylolpropane Coconut Ether Phenoxyethanol Edetate Disodium Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-07-29

Description

Drug Facts

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Drug Facts

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.
Section 42229-5

Drug Facts

Section 50565-1

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
Section 50566-9

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

Section 50567-7

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

Warnings

For external use only.

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.
Active Ingredients

Zinc Oxide 14.5%

Octinoxate 7.5%

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

[email protected]


Structured Label Content

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.
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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
Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

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

Purpose

Sunscreen

Warnings

For external use only.

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.
Active Ingredients (Active ingredients)

Zinc Oxide 14.5%

Octinoxate 7.5%

Inactive Ingredients (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 (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

[email protected]


Advanced Ingredient Data


Raw Label Data

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