allies of skin: the one spf-50 invisible sunscreen gel

SPL v4

SPL

SPL Set ID 36e1c61c-33ab-4a5d-853d-119c29632b08

Route

topical

Published

Effective Date 2025-06-06

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

avobenzone (30 mg) homosalate (70 mg) octocrylene (100 mg) octisalate (50 mg)

Inactive Ingredients

isododecane dimethicone/bis-isobutyl ppg-20 crosspolymer butyloctyl salicylate medium-chain triglycerides tridecyl salicylate aloe vera leaf green tea leaf watermelon carrot glycyrrhiza glabra helianthus annuus flowering top punica granatum root bark rosemary niacinamide tetrahexyldecyl ascorbate tocopherol

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2023-12-11

Purpose

Sunscreen

Description

Avobenzone 3.00%, Homosalate 7.00%, Octocrylene 10.00%, Octisalate 5.00%

Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.00%, Homosalate 7.00%, Octocrylene 10.00%, Octisalate 5.00%

Uses:

• Helps prevent sunburn. • Higher SPF gives sunburn protection. • 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.

Drug Facts

Directions:

• Apply liberally 15 minutes before sun exposure and as needed. • children under 6 months of age: ask a doctor.Reapply:• after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours

• 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 broad spectrum SPF of 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10 a.m. – 2 p.m. • Wear long-sleeved shirts, pants, hats and sunglasses.

Active Ingredients

Avobenzone 3.00%,

Homosalate 7.00%,

Octocrylene 10.00%,

Octisalate 5.00%

Other Information:

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

Package Labeling:3ml

Package Labeling:50ml

Package Labeling:90ml

Package Labeling: 20ml

When Using This Product

• keep out of eyes. Rinse with water to remove.

inactive Ingredients:

Isododecane, Dimethicone/bis-lsobutyl PPG-20 Crosspolymer, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Tridecyl Salicylate, Aloe Barbadensis Leaf Extract, Camellia Sinensis (Green Tea) Extract, Citrullus Lanatus (Watermelon) Extract, Daucus Carota Sativa (Carrot) Extract, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) Oil, Punica Granatum (Pomegranate) Extract, Rosmarinus Officinalis (Rosemary) Extract, Rubus Idaeus (Raspberry) Oil, Niacinamide, Tetrahexyldecyl Ascorbate (Vitamin C), Tocopherol (Vitamin E)

Stop Use and Ask A Doctor If

• rash or irritation develops and lasts.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

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

Structured Label Content

Purpose

Sunscreen

Uses:

• Helps prevent sunburn. • Higher SPF gives sunburn protection. • 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 (Do not use)

• on damaged or broken skin.

Drug Facts

Directions:

• Sun Protection Measures:

Active Ingredients

Avobenzone 3.00%,

Homosalate 7.00%,

Octocrylene 10.00%,

Octisalate 5.00%

Other Information:

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

Package Labeling:3ml

Package Labeling:50ml

Package Labeling:90ml

Package Labeling: 20ml

When Using This Product (When using this product)

• keep out of eyes. Rinse with water to remove.

inactive Ingredients: (Inactive Ingredients:)

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

• rash or irritation develops and lasts.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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

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Raw Label Data

All Sections (JSON)

{"Uses:": "• Helps prevent sunburn. • Higher SPF gives sunburn protection. • 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.", "Directions:": "• Apply liberally 15 minutes before sun exposure and as needed. • children under 6 months of age: ask a doctor.Reapply:• after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • 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 broad spectrum SPF of 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10 a.m. – 2 p.m. • Wear long-sleeved shirts, pants, hats and sunglasses.", "Active Ingredients": "Avobenzone 3.00%, Homosalate 7.00%, Octocrylene 10.00%, Octisalate 5.00%", "Other Information:": "• Protect this product in this container from excessive heat and direct sun.", "When using this product": "• keep out of eyes. Rinse with water to remove.", "Inactive Ingredients:": "Isododecane, Dimethicone/bis-lsobutyl PPG-20 Crosspolymer, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Tridecyl Salicylate, Aloe Barbadensis Leaf Extract, Camellia Sinensis (Green Tea) Extract, Citrullus Lanatus (Watermelon) Extract, Daucus Carota Sativa (Carrot) Extract, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) Oil, Punica Granatum (Pomegranate) Extract, Rosmarinus Officinalis (Rosemary) Extract, Rubus Idaeus (Raspberry) Oil, Niacinamide, Tetrahexyldecyl Ascorbate (Vitamin C), Tocopherol (Vitamin E)", "Stop use and ask a doctor if": "• rash or irritation develops and lasts.", "If pregnant or breast-feeding,": "ask a health professional before use.", "Keep out of reach of children.": "If swallowed, get medical help or contact a Poison Control Center right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:17.003622 · Updated: 2026-03-14T23:08:57.795400