Sun's Out, Fun's Out Kit

Sun's Out, Fun's Out Kit
SPL v1
SPL
SPL Set ID 46040acf-512e-c867-e063-6294a90ac220
Route
TOPICAL
Published
Effective Date 2025-12-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (10 g) Homosalate (3 g) Avobenzone (5 g) Octisalate (30 mg)
Inactive Ingredients
Citral .alpha.-hexylcinnamaldehyde Dibutyl Ethylhexanoyl Glutamide Benzyl Salicylate Octyldodecyl Neopentanoate Ferric Oxide Red Linalool, (+)- Alkyl (c12-15) Benzoate Sunflower Oil Ginger Isostearyl Linoleate Soybean Oil Tocopherol Coconut Oil Magnesium Potassium Aluminosilicate Fluoride Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) Butyloctyl Salicylate Levomenol Silicon Dioxide Farnesol Dibutyl Lauroyl Glutamide Octyldodecanol Aloe Vera Leaf Tert-butyl Alcohol Linalool, (+/-)- Diisopropyl Adipate Hydrogenated Castor Oil Hyaluronate Sodium Castor Oil Alcohol Dicaprylyl Carbonate Tetrahexyldecyl Ascorbate Dibutyl Maleate Stannic Oxide Titanium Dioxide Mica Avocado Oil Hibiscus Sabdariffa Seed Oil Kukui Nut Oil Macadamia Oil .alpha.-tocopherol Acetate Polyamide-3 (12000 Mw) Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-12
Description

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

Purpose

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

Medication Information

Purpose

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

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

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

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

Description

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

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

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

Kopari

Sun's Out

Fun's Out

Full Size

Section 53413-1

Call (858) 252-0099

Warnings

For external use only

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

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octocrylene 10%

Octisalate 5%

Questions/comments

Call (858) 252-0099

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)

Questions Or Comments?

Call (858) 252-0099

Structured Label Content

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

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)

Kopari

Sun's Out

Fun's Out

Full Size

Section 53413-1 (53413-1)

Call (858) 252-0099

Purpose

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

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

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

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

Warnings

For external use only

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

Active Ingredients (Active ingredients)

Avobenzone 3%

Homosalate 10%

Octocrylene 10%

Octisalate 5%

Questions/comments (Questions/Comments)

Call (858) 252-0099

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)

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: 2026-02-15T12:07:44.144350 · Updated: 2026-03-14T23:11:28.912883