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

Warnings

For external use only.

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.
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.

Description

Drug Facts

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
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

Warnings

For external use only.

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.
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.

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
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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