SPL v1
SPL
SPL Set ID 30d34459-b7fb-b0c6-e063-6294a90a08ac
Route
TOPICAL
Published
Effective Date 2025-03-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (3.5 g) Homosalate (19.2 g) Zinc Oxide
Inactive Ingredients
Silica Triethoxycaprylylsilane Peg-10 Dimethicone (200 Cst) Lauroyl Lysine Linolenic Acid Ethylhexylglycerin Carthamus Tinctorius (safflower) Flower Polygonum Cuspidatum Root Tocopherol Buddleja Officinalis Flower Camellia Sinensis Leaf Sodium Hyaluronate Diospyros Kaki Leaf Castanea Crenata Shell Maritime Pine Magnesium Sulfate Ci 77492 Benzotriazolyl Dodecyl P-cresol Trisiloxane Tara Spinosa Fruit Kappaphycus Alvarezii Butylene Glycol Zanthoxylum Piperitum Fruit Pulp Dicaprylyl Carbonate Hydroxyacetophenone Octyldodecanol Lauryl Peg-9 Polydimethylsiloxyethyl Dimethicone Disteardimonium Hectorite Water Diphenylsiloxy Phenyl Trimethicone Methyl Trimethicone Vitis Vinifera (grape) Arabica Coffee Bean Ci 77491 Polyglyceryl-4 Isostearate 1,2-hexanediol Isopropyl Titanium Triisostearate 3-o-ethyl Ascorbic Acid Niacinamide Caprylyl Methicone Butyloctyl Salicylate Propanediol Sodium Chloride Isododecane

Identifiers & Packaging

Pill Appearance
Color: orange
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-01

Description

Homosalate 3.5%, Octisalate 3.5%, Zinc Oxide 19.2%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Homosalate 3.5%, Octisalate 3.5%, Zinc Oxide 19.2%

Use
  • Helps prevent sunbum.
  • 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.
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 and ask a doctor if

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

Other Information
  • Protect the product in this container from excessive heat and direct sun.
Active Ingredients

Homosalate 3.5%,

Octisalate 3.5%, Zinc Oxide 19.2%

Inactive Ingredients

Water(Aqqua/Eau), Butyloctyl Salicylate, Propanediol, Diphenylsiloxy Phenyl Trimethicone, Polypropylsilsesquioxane, Lauryl PEG-9

Polydimethylsiloxyethyl Dimethicone, Silica, Benzotriazolyl Dodecyl p-Cresol, Capryiyl Methicone, Methyl Trimethicone, Trisiloxane, Cetyl PEG/PPG-10/1 Dimethicone, Phenyl Propyl Trimethicone, Disteardimonium Hectorite, Dimethicone/inyl Dimethicone Crosspolymer, Triethoxycaprylylsilane, 1,2-Hexanediol, Lauryl Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, PEG-10 Dimethicone, Sodium Chloride, Dicaprylyl Carbonate, Magnesium Sulfate, Hydroxyacetophenone, Lauroyl Lysine, Iron Oxides (CI 77492), Isododecane, Octyldodecanol, iron Oxides (C 77491), Polyglyceryl-4 Isostearate, Isopropyl Titanium Triisostearate, Tocopherol, 3-0-Ethyl Ascorbic Acid, Niacinamide, Sodium Hyaluronate, Caesalpinia Spinosa Fruit Extract, Kappaphycus Alvarezi Extract, Butylene Glycol, Linolenic Acid, Buddleja Officinalis Flower Extract, Diospyros Kaki Leaf Extract, Ethylhexylglycerin, Vitis

Vinifera (Grape) Fruit Extract, Carthamus Tinctorius (Safflower) Flower Extract, Coffea Arabica (Coffee) Seed Extract, Polygonum Cuspidatum Root Extract, Camelia Sinensis Leaf Extract, Castanea Crenata (Chestnut) Shell Extract, Zanthoxylum Piperitum Fruit Extract, Pinus Pinaster Bark Extract

Questions Or Comments?

Contact to www.dr-g.com

Keep Out of Reach of Children.

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


Structured Label Content

Use
  • Helps prevent sunbum.
  • 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.
Purpose

Sunscreen

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 and ask a doctor if

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

Other Information (Other information)
  • Protect the product in this container from excessive heat and direct sun.
Active Ingredients (Active ingredients)

Homosalate 3.5%,

Octisalate 3.5%, Zinc Oxide 19.2%

Inactive Ingredients (Inactive ingredients)

Water(Aqqua/Eau), Butyloctyl Salicylate, Propanediol, Diphenylsiloxy Phenyl Trimethicone, Polypropylsilsesquioxane, Lauryl PEG-9

Polydimethylsiloxyethyl Dimethicone, Silica, Benzotriazolyl Dodecyl p-Cresol, Capryiyl Methicone, Methyl Trimethicone, Trisiloxane, Cetyl PEG/PPG-10/1 Dimethicone, Phenyl Propyl Trimethicone, Disteardimonium Hectorite, Dimethicone/inyl Dimethicone Crosspolymer, Triethoxycaprylylsilane, 1,2-Hexanediol, Lauryl Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, PEG-10 Dimethicone, Sodium Chloride, Dicaprylyl Carbonate, Magnesium Sulfate, Hydroxyacetophenone, Lauroyl Lysine, Iron Oxides (CI 77492), Isododecane, Octyldodecanol, iron Oxides (C 77491), Polyglyceryl-4 Isostearate, Isopropyl Titanium Triisostearate, Tocopherol, 3-0-Ethyl Ascorbic Acid, Niacinamide, Sodium Hyaluronate, Caesalpinia Spinosa Fruit Extract, Kappaphycus Alvarezi Extract, Butylene Glycol, Linolenic Acid, Buddleja Officinalis Flower Extract, Diospyros Kaki Leaf Extract, Ethylhexylglycerin, Vitis

Vinifera (Grape) Fruit Extract, Carthamus Tinctorius (Safflower) Flower Extract, Coffea Arabica (Coffee) Seed Extract, Polygonum Cuspidatum Root Extract, Camelia Sinensis Leaf Extract, Castanea Crenata (Chestnut) Shell Extract, Zanthoxylum Piperitum Fruit Extract, Pinus Pinaster Bark Extract

Questions Or Comments? (Questions or comments?)

Contact to www.dr-g.com

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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