(malin+goetz) Spf 30 Mineral Sunscreen

(malin+goetz) Spf 30 Mineral Sunscreen
SPL v3
SPL
SPL Set ID f3d39df9-1618-7014-e053-2995a90af7bb
Route
TOPICAL
Published
Effective Date 2022-12-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (3.71 g) Zinc Oxide (2.71 g)
Inactive Ingredients
Diethylhexyl Syringylidenemalonate Benzyl Alcohol Phenoxyethanol Shea Butter Polysorbate 60 Sorbitan Isostearate Ursolic Acid Stearic Acid Hydrogenated Soybean Lecithin Glycerin Coconut Alkanes Xanthan Gum Citric Acid Monohydrate Isohexadecane Water Aluminum Oxide Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Hyaluronate Sodium Polyhydroxystearic Acid (2300 Mw) .alpha.-tocopherol Acetate Coco-caprylate/caprate Aminomethylpropanol Medium-chain Triglycerides Niacinamide Glycogen Triethoxycaprylylsilane

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-12-15

Description

Active Ingredient Purpose Titanium Dioxide 3.71% Sunscreen Zinc Oxide 2.71% Sunscreen


Medication Information

Warnings and Precautions

Warnings: For external use only

Do not use on damaged or broken skin

When using this product

  • Keep out of eyes. RInse with water to remove
Indications and Usage

Stop use and ask a doctor

  • if rash occurs
Dosage and Administration

Directions

  • Apply liberally and evenly 15 minutes before sun exposure
  • Children under 6 months of age: ask a doctor

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 value of 15 or higher and other sun protection measures including:

limit your time in the sun, especially from 10a.m. – 2 p.m.

  • wear long-sleeved shirts, pants, hats, and sunglasses
  • reapply after 40 minutes of swimming or sweating
  • Immediately after towel drying
  • At least every 2 hours
Description

Active Ingredient Purpose Titanium Dioxide 3.71% Sunscreen Zinc Oxide 2.71% Sunscreen

Section 50565-1

Keep out of reach of children

Section 51727-6

Inactive ingredients

Water/Aqua/Eau, Glycerin, Caprylic/Capric Triglyceride, Butyrospermum Parkii (Shea) Butter, Niacinamide, Coconut Alkanes, Alumina, Glycogen, Isohexadecane, Polysorbate 60, Sorbitan Isostearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Sodium Hyaluronate, Diethylhexyl Syringlidenemalonate, Triethoxycaprylylsilane, Ursolic Acid, Stearic Acid, Polyhydroxystearic Acid, hydrogenated Lecithin, Benzyl Alcohol, Phenoxyethanol, Tocopheryl Acetate, Coco-Caprylate/Caprate, Aminomethyl Propanol, Xanthan Gum, Citric Acid.

Section 51945-4

(Malin+Goetz)

spf 30 mineral sunscreen

Broad Spectrum

Water-Resistant 40 minutes

1.7 fl.oz./50 ml

Section 55105-1

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 55106-9

Active Ingredient Purpose

Titanium Dioxide 3.71% Sunscreen

Zinc Oxide 2.71% Sunscreen


Structured Label Content

Indications and Usage (34067-9)

Stop use and ask a doctor

  • if rash occurs
Dosage and Administration (34068-7)

Directions

  • Apply liberally and evenly 15 minutes before sun exposure
  • Children under 6 months of age: ask a doctor

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 value of 15 or higher and other sun protection measures including:

limit your time in the sun, especially from 10a.m. – 2 p.m.

  • wear long-sleeved shirts, pants, hats, and sunglasses
  • reapply after 40 minutes of swimming or sweating
  • Immediately after towel drying
  • At least every 2 hours
Warnings and Precautions (34071-1)

Warnings: For external use only

Do not use on damaged or broken skin

When using this product

  • Keep out of eyes. RInse with water to remove
Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

Inactive ingredients

Water/Aqua/Eau, Glycerin, Caprylic/Capric Triglyceride, Butyrospermum Parkii (Shea) Butter, Niacinamide, Coconut Alkanes, Alumina, Glycogen, Isohexadecane, Polysorbate 60, Sorbitan Isostearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Sodium Hyaluronate, Diethylhexyl Syringlidenemalonate, Triethoxycaprylylsilane, Ursolic Acid, Stearic Acid, Polyhydroxystearic Acid, hydrogenated Lecithin, Benzyl Alcohol, Phenoxyethanol, Tocopheryl Acetate, Coco-Caprylate/Caprate, Aminomethyl Propanol, Xanthan Gum, Citric Acid.

Section 51945-4 (51945-4)

(Malin+Goetz)

spf 30 mineral sunscreen

Broad Spectrum

Water-Resistant 40 minutes

1.7 fl.oz./50 ml

Section 55105-1 (55105-1)

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 55106-9 (55106-9)

Active Ingredient Purpose

Titanium Dioxide 3.71% Sunscreen

Zinc Oxide 2.71% Sunscreen


Advanced Ingredient Data


Raw Label Data

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