84558-007

84558-007
SPL v1
SPL
SPL Set ID 2dc0ee9b-d58b-fe40-e063-6394a90af439
Route
CUTANEOUS
Published
Effective Date 2025-02-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (2.76 g) Ethylhexyl Salicylate (5 g) Phenylbenzimidazole Sulfonic Acid (3.2 g) Zinc Oxide (2.85 g)
Inactive Ingredients
Aluminum Hydroxide Sorbitan Sesquioleate Propanediol Peg-9 Diglycidyl Ether/sodium Hyaluronate Crosspolymer Xanthan Gum Sodium Hyaluronate Caprylhydroxamic Acid Sodium S-(2-hydroxy-3-(3-(trihydroxysilyl)propoxy)propyl) Sulfurothioate Triethoxycaprylylsilane Alpha-tocopherol Acetate Lactic Acid Centella Asiatica Triterpenoids Hydrolyzed Casein (enzymatic; 1000 Mw) Sodium Acetylated Hyaluronate Hyaluronic Acid Aqua Glycerin Silica Butylene Glycol Neopentyl Glycol Diheptanoate Cyclopentasiloxane Isohexadecane Cetyl Peg/ppg-10/1 Dimethicone (hlb 4) C12-15 Alkyl Benzoate Cyclohexasiloxane Niacinamide Magnesium Sulfate Disteardimonium Hectorite Madecassoside 1,2-hexanediol Peg-10 Dimethicone (200 Cst) Hydroxyacetophenone Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-10
Description

Zinc Oxide 2.85% Titanium Dioxide 2.76% EthylhexyI Salicylate 5% Phenylbenzimidazole Sulfonic Acid 3.2%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 2.85% Titanium Dioxide 2.76% EthylhexyI Salicylate 5% Phenylbenzimidazole Sulfonic Acid 3.2%

Use

● Helps prevent sunburn.

● Ifused 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 Center 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)

Zinc Oxide 2.85%

Titanium Dioxide 2.76%

EthylhexyI Salicylate 5%

Phenylbenzimidazole Sulfonic Acid 3.2%

Inactive Ingredients

Aqua, Glycerin, Silica, Butylene Glycol, Neopenty|l Gly-col Diheptanoate, Cyclopentasiloxane, Isohexadecane,

Cety| Peg/Ppg-10/1 Dimethicone, C12-15 AlkyI Benzo-ate, Cyclohexasiloxane, Niacinamide, Magnesium Sul-

fate, Disteardimonium Hectorite, Madecassoside,1,2-Hexanediol, Peg-10 Dimethicone, Sorbitan Sesqui-

oleate, Hydroxyacetophenone, Sodium Hydroxide,

Package Label Principal Display Panel

Structured Label Content

Use

● Helps prevent sunburn.

● Ifused 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 Center 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)

Zinc Oxide 2.85%

Titanium Dioxide 2.76%

EthylhexyI Salicylate 5%

Phenylbenzimidazole Sulfonic Acid 3.2%

Inactive Ingredients (Inactive ingredients)

Aqua, Glycerin, Silica, Butylene Glycol, Neopenty|l Gly-col Diheptanoate, Cyclopentasiloxane, Isohexadecane,

Cety| Peg/Ppg-10/1 Dimethicone, C12-15 AlkyI Benzo-ate, Cyclohexasiloxane, Niacinamide, Magnesium Sul-

fate, Disteardimonium Hectorite, Madecassoside,1,2-Hexanediol, Peg-10 Dimethicone, Sorbitan Sesqui-

oleate, Hydroxyacetophenone, Sodium Hydroxide,

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:31.511669 · Updated: 2026-03-14T23:07:26.290118