29d492c5-f0c4-487d-e063-6394a90a31e1

SPL v6
SPL
SPL Set ID 29d492c5-f0c4-487d-e063-6394a90a31e1
Route
topical
Published
Effective Date 2025-01-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
titanium dioxide (114 mg) zinc oxide (55 mg)
Inactive Ingredients
carbomer triethanolamine sodium benzoate cyclopentasiloxane octyldodecyl neopentanoate vinylpyrrolidone/eicosene copolymer glyceryl stearate peg-100 stearate cetyl alcohol olea europaea (olive) fruit oil simmondsia chinensis (jojoba) seed oil millet ruscus aculeatus root comfrey plantago ovata seed hydrolyzed wheat protein (enzymatic, 3000 mw) polyhydroxystearic acid (2300 mw) hexyldecanol xanthan gum dimethiconol (40 cst) trisodium edta phenoxyethanol ethylhexylglycerin caprylic/capric triglyceride hydrogen dimethicone (20 cst) alumina persea gratissima (avocado) oil .alpha.-tocopherol acetate .delta.-tocopherol egg phospholipids magnesium aluminum silicate oatmeal citric acid squalane carob triethoxycaprylylsilane water diglycerin lysine pca ceramide 3 phenyl trimethicone cyclomethicone

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-01-31

Description

Active ingredients: Titanium Dioxide 7.9 % Zinc Oxide 5.9 %


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.

Stop use end ask a doctor if rash occurs.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center

right away.

Active Ingredient

Active ingredients:

Titanium Dioxide 7.9 %

Zinc Oxide 5.9 %

Indications and Usage

Directions:

Apply liberally 30 minutes before sun exposure.

Reapply:

  • after 40 minutes of swimming or sweating,
  • immediately after towel drying,
  • at least every 2 hours.
Dosage and Administration

Directions:

Apply liberally 15 minutes before sun exposure

Reapply:

  • after 40 minutes of swimming or sweating,
  • immediately after towel drying,
  • at least every 2 hours.
Description

Active ingredients: Titanium Dioxide 7.9 % Zinc Oxide 5.9 %

Section 43685-7

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 sun protection measures

including:

  • limit time in the sun, especially from10 a.m. – 2 p.m.
  • wear long sleeve shirts, pants, hats, and sunglasses,
  • children under 6 months: Ask a doctor.
Section 50565-1

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center

right away.

Section 51727-6

Water (Deionized)

Caprylic/Capric Triglyceride

Octyldodecyl Neopentanoate

VP/Eicosene Copolymer

Squalane (Veg. Origin)

Cyclopentasiloxane

Glyceryl Stearate

PEG-100 Stearate

Cetyl Alcohol

Hydrogen Dimethicone

Alumina

Olea Europaea (Olive) Fruit Oil

Persea Gratissima (Avocado) Oil

Simmondsia Chinensis (Jojoba) Seed Oil

Tocopheryl Acetate (Natural)

Glycerin

Tocopherol

Lysine PCA

Ceramide-3

Panicum Miliaceum (Millet) Seed Extract

Ceratonia Siliqua (Carob) Gum

Phospholipids

Ruscus Aculeatus Root Extract (Butcherbroom)

Avena Sativa (Oat) Kernel Protein

Symphytum Officinale Extract (Comfrey)

Plantago Ovata Seed Extract (Plantain)

Hydrolyzed Wheat Protein

Magnesium Aluminum Silicate

Polyhydroxystearic Acid

Phenyl Trimethicone

Hexyldecanol

Xanthan Gum

Cyclomethicone

Citric Acid

Triethoxycaprylylsilane

Dimethiconol

Propylene Glycol

Carbomer

Triethanolamine

Trisodium EDTA

Phenoxyethanol

Ethylhexylglycerin

Sodium Benzoate

Fragrance

Section 51945-4

Section 55105-1

Sunscreen

  • helps prevent sunburn
  • if used as direct with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun

Structured Label Content

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.

Stop use end ask a doctor if rash occurs.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center

right away.

Active Ingredient (55106-9)

Active ingredients:

Titanium Dioxide 7.9 %

Zinc Oxide 5.9 %

Indications and Usage (34067-9)

Directions:

Apply liberally 30 minutes before sun exposure.

Reapply:

  • after 40 minutes of swimming or sweating,
  • immediately after towel drying,
  • at least every 2 hours.
Dosage and Administration (34068-7)

Directions:

Apply liberally 15 minutes before sun exposure

Reapply:

  • after 40 minutes of swimming or sweating,
  • immediately after towel drying,
  • at least every 2 hours.
Section 43685-7 (43685-7)

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 sun protection measures

including:

  • limit time in the sun, especially from10 a.m. – 2 p.m.
  • wear long sleeve shirts, pants, hats, and sunglasses,
  • children under 6 months: Ask a doctor.
Section 50565-1 (50565-1)

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center

right away.

Section 51727-6 (51727-6)

Water (Deionized)

Caprylic/Capric Triglyceride

Octyldodecyl Neopentanoate

VP/Eicosene Copolymer

Squalane (Veg. Origin)

Cyclopentasiloxane

Glyceryl Stearate

PEG-100 Stearate

Cetyl Alcohol

Hydrogen Dimethicone

Alumina

Olea Europaea (Olive) Fruit Oil

Persea Gratissima (Avocado) Oil

Simmondsia Chinensis (Jojoba) Seed Oil

Tocopheryl Acetate (Natural)

Glycerin

Tocopherol

Lysine PCA

Ceramide-3

Panicum Miliaceum (Millet) Seed Extract

Ceratonia Siliqua (Carob) Gum

Phospholipids

Ruscus Aculeatus Root Extract (Butcherbroom)

Avena Sativa (Oat) Kernel Protein

Symphytum Officinale Extract (Comfrey)

Plantago Ovata Seed Extract (Plantain)

Hydrolyzed Wheat Protein

Magnesium Aluminum Silicate

Polyhydroxystearic Acid

Phenyl Trimethicone

Hexyldecanol

Xanthan Gum

Cyclomethicone

Citric Acid

Triethoxycaprylylsilane

Dimethiconol

Propylene Glycol

Carbomer

Triethanolamine

Trisodium EDTA

Phenoxyethanol

Ethylhexylglycerin

Sodium Benzoate

Fragrance

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

  • helps prevent sunburn
  • if used as direct with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun

Advanced Ingredient Data


Raw Label Data

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