Tinted Mineral Sunscreen

Tinted Mineral Sunscreen
SPL v5
SPL
SPL Set ID 13e5085f-df2b-46b2-b063-e58ce4379905
Route
TOPICAL
Published
Effective Date 2023-02-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (110 mg) Titanium Dioxide (75 mg)
Inactive Ingredients
Water Dimethicone Methyl Trimethicone Isononyl Isononanoate Oleth-3 Phosphate Peg-9 Polydimethylsiloxyethyl Dimethicone Aluminum Oxide Butylene Glycol Octyldodecyl Neopentanoate Vinylpyrrolidone/eicosene Copolymer Hyaluronate Sodium .alpha.-tocopherol Acetate Caffeine Polysorbate 20 Sodium Acrylate/sodium Acryloyldimethyltaurate Copolymer (4000000 Mw) Dexpanthenol Cetostearyl Alcohol Dihexadecyl Phosphate Ceteth-20 Phosphate Triethoxysilane Xanthan Gum Sodium Hydroxide Phenoxyethanol Edetate Disodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-11-10

Description

Drug Facts


Medication Information

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.

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.

Section 55105-1
Active ingredient Purpose
Zinc Oxide 11% Sunscreen
Titanium Dioxide 7.5% 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.
Inactive Ingredients

Purified Water, Dimethicone, Methyl Trimethicone, Isononyl Isononanoate, Oleth-3 Phosphate, PEG-9 Polydimethylsiloxyethyl Dimethicone, Alumina, Butylene Glycol, Octyldodecyl Neopentanoate, VP/Eicosene Copolymer, Sodium Hyaluronate, Tocopheryl Acetate, Caffeine, Polyisobutene, Iron Oxides, Sucrose, Glycerin, Silicone, Isopropyl Titanium Triisostearate, Polysorbate 20, Polyacrylate-13, Panthenol, Cetearyl Alcohol, Dicetyl Phosphate, Ceteth-20 Phosphate, PEG-8 Methyl Ether Triethoxysilane, Hydrogen Dimethicone Polyglyceryl-6 Polyricinoleate, Xanthan Gum, Sodium Hydroxide, Phenoxyethanol, Disodium EDTA.

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
Principal Display Panel 99 G Bottle Label

COMPLIMENTS OF

TOPIX

PHARMACEUTICALS, INC

MULTI-TASKING

Mineral

Lightly Tinted

Antioxidant

Sunscreen

SPF 50+

Broad Spectrum SPF 50+

Water Resistant 40 minutes

Net wt. 3.5 oz. (99 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.

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.

Section 55105-1 (55105-1)
Active ingredient Purpose
Zinc Oxide 11% Sunscreen
Titanium Dioxide 7.5% 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.
Inactive Ingredients (Inactive ingredients)

Purified Water, Dimethicone, Methyl Trimethicone, Isononyl Isononanoate, Oleth-3 Phosphate, PEG-9 Polydimethylsiloxyethyl Dimethicone, Alumina, Butylene Glycol, Octyldodecyl Neopentanoate, VP/Eicosene Copolymer, Sodium Hyaluronate, Tocopheryl Acetate, Caffeine, Polyisobutene, Iron Oxides, Sucrose, Glycerin, Silicone, Isopropyl Titanium Triisostearate, Polysorbate 20, Polyacrylate-13, Panthenol, Cetearyl Alcohol, Dicetyl Phosphate, Ceteth-20 Phosphate, PEG-8 Methyl Ether Triethoxysilane, Hydrogen Dimethicone Polyglyceryl-6 Polyricinoleate, Xanthan Gum, Sodium Hydroxide, Phenoxyethanol, Disodium EDTA.

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
Principal Display Panel 99 G Bottle Label (PRINCIPAL DISPLAY PANEL - 99 g Bottle Label)

COMPLIMENTS OF

TOPIX

PHARMACEUTICALS, INC

MULTI-TASKING

Mineral

Lightly Tinted

Antioxidant

Sunscreen

SPF 50+

Broad Spectrum SPF 50+

Water Resistant 40 minutes

Net wt. 3.5 oz. (99 g)

Available

Custom Branded

800.445.2595

[email protected]


Advanced Ingredient Data


Raw Label Data

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