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
Purpose

Sunscreen

Description

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

Medication Information

Warnings

For external use only

Purpose

Sunscreen

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



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.

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,

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

Do Not Use

Do not use on damaged or broken skin

Active Ingredient(s)

Zinc Oxide 2.85%

Titanium Dioxide 2.76%

EthylhexyI Salicylate 5%

Phenylbenzimidazole Sulfonic Acid 3.2%

Package Label Principal Display Panel

Structured Label Content

Warnings

For external use only

Purpose

Sunscreen

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



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.

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,

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

Do Not Use (Do not use)

Do not use on damaged or broken skin

Active Ingredient(s)

Zinc Oxide 2.85%

Titanium Dioxide 2.76%

EthylhexyI Salicylate 5%

Phenylbenzimidazole Sulfonic Acid 3.2%

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