sun on the run kit

sun on the run kit
SPL v1
SPL
SPL Set ID 1c351485-0998-e308-e063-6394a90a9ee6
Route
topical
Published
Effective Date 2024-07-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
homosalate (10 g) octisalate (5 g) octocrylene (3 g) avobenzone (50 mg)
Inactive Ingredients
soybean oil farnesol citral .alpha.-hexylcinnamaldehyde benzyl salicylate linalool, (+)- ginger coconut oil butyloctyl salicylate alkyl (c12-15) benzoate octyldodecanol isostearyl linoleate dibutyl lauroyl glutamide tocopherol magnesium potassium aluminosilicate fluoride silicon dioxide ferric oxide red sunflower oil aloe vera leaf octyldodecyl neopentanoate polyester-8 (1400 mw, cyanodiphenylpropenoyl capped) dibutyl ethylhexanoyl glutamide levomenol macadamia oil kukui nut oil titanium dioxide mica pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) avocado oil hibiscus sabdariffa seed oil .alpha.-tocopherol acetate polyamide-3 (12000 mw) medium-chain triglycerides isododecane dimethicone/vinyl dimethicone crosspolymer (hard particle) stannous oxide caprylyl trisiloxane dimethicone/bis-isobutyl ppg-20 crosspolymer

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-07-01
Purpose

Avobenzone 3% .........................Sunscreen Homosalate 10%.........................Sunscreen Octocrylene 10% ........................Sunscreen Octisalate 5% .............................Sunscreen

Description

Avobenzone 3% Homosalate 10% Octocrylene 10% Octisalate 5%

Medication Information

Warnings

For external use only

Uses

• Helps prevent sunburn

• If used as directed with other sunprotection measures (see Directions),decreases the risk of skin cancer and earlyskin aging caused by the sun

Purpose

Avobenzone 3% .........................Sunscreen

Homosalate 10%.........................Sunscreen

Octocrylene 10% ........................Sunscreen

Octisalate 5% .............................Sunscreen

Directions

• Apply generously & evenly 15 minutesbefore sun exposure.

REAPPLY: After 40 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 a Broad Spectrum SPF value 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 • Children under 6 months: Ask a doctor

Other Information

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

Inactive Ingredients

Octyldodecanol, C12-15 Alkyl Benzoate, Polyamide-3, Butyloctyl Salicylate, Octyldodecyl Neopentanoate, Fragrance (Parfum), Persea Gratissima (Avocado) Oil, Hibiscus Sabdariffa Seed Oil, Cocos Nucifera (Coconut) Oil, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Aleurites Moluccana Seed Oil, Tocopheryl Acetate, Macadamia Ternifolia Seed Oil, Benzyl Salicylate, Hexyl Cinnamal, Linalool, Mica (CI 77019), Titanium Dioxide (CI 77891), Iron Oxides (CI 77491).

Description

Avobenzone 3% Homosalate 10% Octocrylene 10% Octisalate 5%

Section 50565-1

Keep out of reach of children

If product is 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

Section 50570-1

Do not use on damaged or broken skin

Section 51945-4

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octocrylene 10%

Octisalate 5%

Questions/comments

Call (858) 252-0099

Questions Or Comments?

Call (858) 252-0099

Structured Label Content

Warnings

For external use only

Uses

• Helps prevent sunburn

• If used as directed with other sunprotection measures (see Directions),decreases the risk of skin cancer and earlyskin aging caused by the sun

Purpose

Avobenzone 3% .........................Sunscreen

Homosalate 10%.........................Sunscreen

Octocrylene 10% ........................Sunscreen

Octisalate 5% .............................Sunscreen

Directions

• Apply generously & evenly 15 minutesbefore sun exposure.

REAPPLY: After 40 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 a Broad Spectrum SPF value 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 • Children under 6 months: Ask a doctor

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

Octyldodecanol, C12-15 Alkyl Benzoate, Polyamide-3, Butyloctyl Salicylate, Octyldodecyl Neopentanoate, Fragrance (Parfum), Persea Gratissima (Avocado) Oil, Hibiscus Sabdariffa Seed Oil, Cocos Nucifera (Coconut) Oil, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Aleurites Moluccana Seed Oil, Tocopheryl Acetate, Macadamia Ternifolia Seed Oil, Benzyl Salicylate, Hexyl Cinnamal, Linalool, Mica (CI 77019), Titanium Dioxide (CI 77891), Iron Oxides (CI 77491).

Section 50565-1 (50565-1)

Keep out of reach of children

If product is 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

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Section 51945-4 (51945-4)

Active Ingredients (Active ingredients)

Avobenzone 3%

Homosalate 10%

Octocrylene 10%

Octisalate 5%

Questions/comments (Questions/Comments)

Call (858) 252-0099

Questions Or Comments? (Questions or comments?)

Call (858) 252-0099

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:14.001506 · Updated: 2026-03-14T23:03:12.694901