84558-006

84558-006
SPL v1
SPL
SPL Set ID 2d9d6440-39b3-312a-e063-6394a90aa072
Route
CUTANEOUS
Published
Effective Date 2024-12-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (4 g) Phenylbenzimidazole Sulfonic Acid (3.2 g) Homosalate (1 g) Zinc Oxide (0.6 g) Ethylhexyl Salicylate (5 g)
Inactive Ingredients
Triethoxycaprylylsilane Lactobacillus Clove Sodium Hydroxide Aqua Dimethicone Glycerin Butylene Glycol Isohexadecane Isononyl Isononanoate Cetyl Peg/ppg-10/1 Dimethicone (hlb 4) Niacinamide Silica Peg-10 Dimethicone (200 Cst) Sodium Chloride Disteardimonium Hectorite 1,2-hexanediol Hydroxyacetophenone Sorbitan Sesquioleate Hyaluronic Acid Caprylhydroxamic Acid Rice Amino Acids Sodium Hyaluronate Alpha-tocopherol Acetate Xanthan Gum Phenoxyethanol Sodium S-(2-hydroxy-3-(3-(trihydroxysilyl)propoxy)propyl) Sulfurothioate Hydrolyzed Casein (enzymatic; 1000 Mw) Propanediol Sodium Acetylated Hyaluronate Peg-9 Diglycidyl Ether/sodium Hyaluronate Crosspolymer Oryza Sativa (rice) Germ Powder Aluminum Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-08

Description

Ethylhexy| Salicylate 5% Titanium Dioxide 4% Phenylbenzimidazole Sulfonic Acid 3.2% Homosalate 1% Zinc Oxide 0.6%

Purpose

Sunscreen .


Medication Information

Purpose

Sunscreen .

Description

Ethylhexy| Salicylate 5% Titanium Dioxide 4% Phenylbenzimidazole Sulfonic Acid 3.2% Homosalate 1% Zinc Oxide 0.6%

Use

1.helps prevent sunburn

2.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 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control C enter right away

Section 50566-9

Stop use and ask a doctor if rash occurs

Section 50567-7

When using this product keep out of eyes. Rinse with water to remove

Warnings

For external use only

Directions

● Apply liberally 15 minutes before sun exposure.

● Children under 6 months of age :Ask a doctor.

● Reapply at least every 2 hours, and after 40 minutes of swimming or sweating.

●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



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.

●Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin

cancer, and other harmful effects of the sun.

Active Ingredient(s)

Ethylhexy| Salicylate 5%

Titanium Dioxide 4%

Phenylbenzimidazole Sulfonic Acid 3.2%

Homosalate 1%

Zinc Oxide 0.6%

Inactive Ingredients

Aqua, Dimethicone, Glycerin, Butylene Glycol, Isohexadec- ane, Isononyl lsononanoate, Cetyl Peg/Ppg-10/1 Di-

methicone, Niacinamide, Slica, Peg-10 Dimethicone, Sodi-um Chloride, Disteardimonium Hectorite, 1,2-Hexanediol,

Hydroxyacetophenone, Sorbitan Sesquioleate, Sodium Hy-droxide, Triethoxyapysilane, Aluminum Hydroxide, Rice

Amino Acids, Oryza Sativa (Rice) Extract, Tocopheryl Ace-tate, Xanthan Gum, L actobacillus/Milk Ferment Filtrate,

Fra-grance, Lactobailus/Soybean Extract Ferment Filtrate, Lac-tobaillus/Rice Ferment, Lactobailus/Rye Flour Ferment,

Bacillus/Soybean Ferment Extract, Phenoxyethanol, Sodium Hyaluronate Crosspolymer, Sodium Hyaluronate, Hydro-

lyzed Sodium Hyaluronate Propanediol, Sodium Acetylated Hyaluronate, Hyaluronic Acid, Hydrolyzed Glycosaminogl-

cans, Hydroxypropytimonium Hyaluronate, Caprylhy-droxamic Acid

Package Label Principal Display Panel


Structured Label Content

Use

1.helps prevent sunburn

2.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 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control C enter right away

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs

Section 50567-7 (50567-7)

When using this product keep out of eyes. Rinse with water to remove

Purpose

Sunscreen .

Warnings

For external use only

Directions

● Apply liberally 15 minutes before sun exposure.

● Children under 6 months of age :Ask a doctor.

● Reapply at least every 2 hours, and after 40 minutes of swimming or sweating.

●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



Do Not Use (Do not use)

Do not use on damaged or broken skin

Other Information (Other information)

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

●Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin

cancer, and other harmful effects of the sun.

Active Ingredient(s)

Ethylhexy| Salicylate 5%

Titanium Dioxide 4%

Phenylbenzimidazole Sulfonic Acid 3.2%

Homosalate 1%

Zinc Oxide 0.6%

Inactive Ingredients (Inactive ingredients)

Aqua, Dimethicone, Glycerin, Butylene Glycol, Isohexadec- ane, Isononyl lsononanoate, Cetyl Peg/Ppg-10/1 Di-

methicone, Niacinamide, Slica, Peg-10 Dimethicone, Sodi-um Chloride, Disteardimonium Hectorite, 1,2-Hexanediol,

Hydroxyacetophenone, Sorbitan Sesquioleate, Sodium Hy-droxide, Triethoxyapysilane, Aluminum Hydroxide, Rice

Amino Acids, Oryza Sativa (Rice) Extract, Tocopheryl Ace-tate, Xanthan Gum, L actobacillus/Milk Ferment Filtrate,

Fra-grance, Lactobailus/Soybean Extract Ferment Filtrate, Lac-tobaillus/Rice Ferment, Lactobailus/Rye Flour Ferment,

Bacillus/Soybean Ferment Extract, Phenoxyethanol, Sodium Hyaluronate Crosspolymer, Sodium Hyaluronate, Hydro-

lyzed Sodium Hyaluronate Propanediol, Sodium Acetylated Hyaluronate, Hyaluronic Acid, Hydrolyzed Glycosaminogl-

cans, Hydroxypropytimonium Hyaluronate, Caprylhy-droxamic Acid

Package Label Principal Display Panel (Package Label - Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

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