Sheet Spf 30 Mineral

Sheet Spf 30 Mineral
SPL v3
SPL
SPL Set ID bbb5b87c-d641-3ba2-e053-2a95a90a0f70
Route
TOPICAL
Published
Effective Date 2021-02-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (100 mg) Zinc Oxide (80 mg)
Inactive Ingredients
Sodium Ascorbyl Phosphate Sodium Hydroxide Aluminum Oxide Ammonium Acryloyldimethyltaurate/vp Copolymer Bis-peg/ppg-16/16 Peg/ppg-16/16 Dimethicone Butylparaben Alkyl (c12-15) Benzoate Medium-chain Triglycerides Polyoxyl 20 Cetostearyl Ether Cetostearyl Alcohol Orange Peel Lemon Peel Cyclomethicone 6 Cyclomethicone 5 Dipropylene Glycol Dibenzoate .alpha.-tocopherol Acetate, Dl- Ethylparaben Glycerin Glyceryl Monostearate Green Tea Leaf Ferric Oxide Red Ferric Oxide Yellow Ferrosoferric Oxide Isopropyl Titanium Triisostearate Methylparaben Phenoxyethanol Fytic Acid Polysorbate 20 Ppg-15 Stearyl Ether Benzoate Propylene Glycol Propylparaben Apple Sugarcane Tert-butyl Alcohol Triethoxycaprylylsilane Water Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2021-01-04 Until 2027-02-28

Description

10% Titanium Dioxide 8% Zinc Oxide

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

10% Titanium Dioxide 8% Zinc Oxide

Uses

• Helps prevent sunburn and provides a sun protection factor of 30. Broad Spectrum. • Ideal for daily use; can be applied under makeup.

Warnings

For external use only.

Directions

Adults and children over 6 months of age:

  • Apply liberally and evenly 15 minutes before sun exposure. 
  • Reapply at least every 2 hours.
  •  Sun Protection Measures: Spending time in the sun increase your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: - limits time in the sun, especially from 10 a.m.–2 p.m. ; and wear long-sleeved shirts, pants, hats, and sunglasses.
Do Not Use

on damaged or broken skin.

Questions?

Call 1 877 484 8437

Product Facts

Other Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

Other Information

Store at room temperature (15-30°C / 59-86°F).

Package Labeling:

Medicinal Ingredients

10% Titanium Dioxide

8% Zinc Oxide

When Using This Product

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Non Medicinal Ingredients

Alumina, Ammonium Acryloyldimethyltaurate/VP Copolymer, Bis-PEG/PPG-16/16 PEG/PPG-16/16 Dimethicone, Butylparaben, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Ceteareth-20, Cetearyl Alcohol, Cetyl Dimethicone, Citrus Aurantium Dulcis (Orange) Peel Extract, Citrus Limon (Lemon) Peel Extract, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dipropylene Glycol Dibenzoate, DL-alpha Tocopheryl Acetate, Ethylparaben, Glycerin, Glyceryl Stearate, Green Tea Extract, Iron Oxides CI 77491, Iron Oxides CI 77492, Iron Oxides CI 77499, Isopropyl Titanium Triisostearate, Methylparaben, Phenoxyethanol, Phytic Acid, Polyhydroxystearic Acid, Polysorbate 20, PPG-15 Stearyl Ether Benzoate, Propylene Glycol, Propylparaben, Pyrus Malus (Apple) Fruit Extract, Saccharum Officinarum (Sugar Cane) Extract, Sodium Ascorbyl Phosphate, Sodium Hydroxide, t-Butyl Alcohol, Triethoxycaprylylsilane, VP/Eicosene Copolymer, Water/Eau, Xanthan Gum.

Stop Use and Ask A Doctor If

rash occurs.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

• Helps prevent sunburn and provides a sun protection factor of 30. Broad Spectrum. • Ideal for daily use; can be applied under makeup.

Purpose

Sunscreen

Warnings

For external use only.

Directions

Adults and children over 6 months of age:

  • Apply liberally and evenly 15 minutes before sun exposure. 
  • Reapply at least every 2 hours.
  •  Sun Protection Measures: Spending time in the sun increase your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: - limits time in the sun, especially from 10 a.m.–2 p.m. ; and wear long-sleeved shirts, pants, hats, and sunglasses.
Do Not Use (Do not use)

on damaged or broken skin.

Questions?

Call 1 877 484 8437

Product Facts

Other Warnings (Other warnings)

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

Other Information (Other information)

Store at room temperature (15-30°C / 59-86°F).

Package Labeling:

Medicinal Ingredients (Medicinal ingredients)

10% Titanium Dioxide

8% Zinc Oxide

When Using This Product (When using this product)

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Non Medicinal Ingredients (Non-medicinal ingredients)

Alumina, Ammonium Acryloyldimethyltaurate/VP Copolymer, Bis-PEG/PPG-16/16 PEG/PPG-16/16 Dimethicone, Butylparaben, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Ceteareth-20, Cetearyl Alcohol, Cetyl Dimethicone, Citrus Aurantium Dulcis (Orange) Peel Extract, Citrus Limon (Lemon) Peel Extract, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dipropylene Glycol Dibenzoate, DL-alpha Tocopheryl Acetate, Ethylparaben, Glycerin, Glyceryl Stearate, Green Tea Extract, Iron Oxides CI 77491, Iron Oxides CI 77492, Iron Oxides CI 77499, Isopropyl Titanium Triisostearate, Methylparaben, Phenoxyethanol, Phytic Acid, Polyhydroxystearic Acid, Polysorbate 20, PPG-15 Stearyl Ether Benzoate, Propylene Glycol, Propylparaben, Pyrus Malus (Apple) Fruit Extract, Saccharum Officinarum (Sugar Cane) Extract, Sodium Ascorbyl Phosphate, Sodium Hydroxide, t-Butyl Alcohol, Triethoxycaprylylsilane, VP/Eicosene Copolymer, Water/Eau, Xanthan Gum.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

rash occurs.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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