Solar Defense Tinted

Solar Defense Tinted
SPL v5
SPL
SPL Set ID 45ec77c5-5ec4-0e51-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2019-10-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (25 mg) Zinc Cation (60 mg)
Inactive Ingredients
1,2-hexanediol Allantoin Aloe Vera Leaf Aluminum Oxide Benzyl Benzoate Benzyl Salicylate Biotin Boron Nitride Butylene Glycol Alkyl (c12-15) Benzoate Calendula Officinalis Flower Camellia Oleifera Leaf Caprylyl Glycol Caprylyl Trisiloxane Cellulose Acetate Cetyl Alcohol Chamomile Chlorphenesin Citral Cucumber Cyclomethicone Dimethicone Edetate Disodium Anhydrous Ethylhexyl Palmitate Acai Glycerin Glyceryl Monocaprylate Glyceryl Monostearate .alpha.-hexylcinnamaldehyde Ferric Oxide Red Ferric Oxide Yellow Ferrosoferric Oxide Lauryl Peg-9 Polydimethylsiloxyethyl Dimethicone Butylphenyl Methylpropional Limonene, (+)- Niacinamide Panthenol Peg-100 Stearate Pentylene Glycol Polysorbate 60 Propanediol Propylene Glycol Monostearate Propylene Glycol Pyridoxine Hydrochloride Sodium Citrate Hyaluronate Sodium Sodium Pyrrolidone Carboxylate Thermus Thermophilus Lysate Triethoxycaprylylsilane Water Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-01-11

Description

Titanium Dioxide (2.5%) Zinc Oxide (6%)

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide (2.5%) Zinc Oxide (6%)

Uses
  • Helps prevent sunburn.
  • If used as directed with other usn protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions
Directions
  • Apply liberally and evenly 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Use a water-resistant sunscreen if swimming or sweating.
  • Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a suncreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Sun Protection Measures.
  • Limit time in the sun, especially from 10 a.m. - 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses.
  • Children under 6 months of age: Ask a doctor
Drug Facts

Do Not Use 

on damaged or broken skin.

Other Information

Protect the product in this container from excessive heat and direct sun.

Package Labeling:

Active Ingredients

Titanium Dioxide (2.5%)

Zinc Oxide (6%)

Inactive Ingredients

1,2-Hexanediol, Acrylates/Ammonium Methacrylate Copolymer, Allantoin, Aloe Barbadensis Leaf Juice, Alpinia Galanga Extract, Alumina, Benzyl Benzoate, Benzyl Salicylate, Biotin, Boron Nitridem, Butylene Glycol, C12-15 Alkyl Benzoate, Calendula Officinalis Flower Extract, Camellia Oleifera Leaf Extract, Caprylyl Glycol, Caprylyl Methicone, Cellulose Acetate, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Chlorphenesin, Citral, Citric Acid Cucumis Sativus (Cucumber) Fruit Extract, Cyclomethicone, Cyclophentasiloxane, Dimethicone , Disodium EDTA, Ethylhexyl Palmitate, Euterpe Oleracea Fruit Extract, Fragrance, Glycerin, Glyceryl Caprylate, Glyceryl Stearate, Hexyl Cinnamal, Hydrolyzed Yeast Protein, Hydroxyethyl Acylate/Sodium Acryloyldimethyl Taurate Copolymer, Iron Oxide (CI 77491), Iron Oxide (CI 77492), Iron Oxide (CI 77499), Lauryl Peg-9 Polydimethylsiloxyethyl Dimethicone, Lilial, Limonene, Niacinamide, Panthenol, PEG-100 Stearate, Pentylene Glycol, Polyhydroxystearic Acid, Polysorbate 60, Propanediol, Propylene Glycol Stearate, Propylene Glycol, Pyridoxine HCl, Sodium Citrate, Sodium Hyaluronate, Sodium PCA, Thermus Thermophilus Ferment, Triethoxycaprylylsilane, Triethoxysilylethyl Polydimethylsiloxyethyl Dimethicone, Water, Xanthan Gum

Questions Or Comments?

Call 1.800.932.9873

When Using This Product 

Keep out of eyes. Rinse with water to remove.

Stop Use and 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.


Structured Label Content

Uses
  • Helps prevent sunburn.
  • If used as directed with other usn protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions
Purpose

Sunscreen

Directions
  • Apply liberally and evenly 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Use a water-resistant sunscreen if swimming or sweating.
  • Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a suncreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Sun Protection Measures.
  • Limit time in the sun, especially from 10 a.m. - 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses.
  • Children under 6 months of age: Ask a doctor
Drug Facts

Do Not Use  (Do not use )

on damaged or broken skin.

Other Information

Protect the product in this container from excessive heat and direct sun.

Package Labeling:

Active Ingredients

Titanium Dioxide (2.5%)

Zinc Oxide (6%)

Inactive Ingredients

1,2-Hexanediol, Acrylates/Ammonium Methacrylate Copolymer, Allantoin, Aloe Barbadensis Leaf Juice, Alpinia Galanga Extract, Alumina, Benzyl Benzoate, Benzyl Salicylate, Biotin, Boron Nitridem, Butylene Glycol, C12-15 Alkyl Benzoate, Calendula Officinalis Flower Extract, Camellia Oleifera Leaf Extract, Caprylyl Glycol, Caprylyl Methicone, Cellulose Acetate, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Chlorphenesin, Citral, Citric Acid Cucumis Sativus (Cucumber) Fruit Extract, Cyclomethicone, Cyclophentasiloxane, Dimethicone , Disodium EDTA, Ethylhexyl Palmitate, Euterpe Oleracea Fruit Extract, Fragrance, Glycerin, Glyceryl Caprylate, Glyceryl Stearate, Hexyl Cinnamal, Hydrolyzed Yeast Protein, Hydroxyethyl Acylate/Sodium Acryloyldimethyl Taurate Copolymer, Iron Oxide (CI 77491), Iron Oxide (CI 77492), Iron Oxide (CI 77499), Lauryl Peg-9 Polydimethylsiloxyethyl Dimethicone, Lilial, Limonene, Niacinamide, Panthenol, PEG-100 Stearate, Pentylene Glycol, Polyhydroxystearic Acid, Polysorbate 60, Propanediol, Propylene Glycol Stearate, Propylene Glycol, Pyridoxine HCl, Sodium Citrate, Sodium Hyaluronate, Sodium PCA, Thermus Thermophilus Ferment, Triethoxycaprylylsilane, Triethoxysilylethyl Polydimethylsiloxyethyl Dimethicone, Water, Xanthan Gum

Questions Or Comments? (Questions or comments?)

Call 1.800.932.9873

When Using This Product  (When using this product )

Keep out of eyes. Rinse with water to remove.

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

if rash occurs.

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

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


Advanced Ingredient Data


Raw Label Data

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