sun essentials spf duo kit

sun essentials spf duo kit
SPL v1
SPL
SPL Set ID 1c329b86-664e-de1f-e063-6394a90a7c23
Route
topical
Published
Effective Date 2024-06-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octocrylene (100 mg) homosalate (50 mg) octisalate (30 mg) avobenzone
Inactive Ingredients
benzyl salicylate octyldodecyl neopentanoate mica octyldodecanol coconut oil titanium dioxide alkyl (c12-15) benzoate butyloctyl salicylate avocado oil macadamia oil linalool, (+)- ferric oxide red pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) kukui nut oil .alpha.-tocopherol acetate .alpha.-hexylcinnamaldehyde polyamide-3 (12000 mw) hibiscus sabdariffa seed oil

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-06-28

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 e xternal 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

Kopari

Sun Shield Body Glow

Sunscreen SPF 50 DUO

Endless Glow, Applies Clear, Absorbs Seamlessly

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octocrylene 10%

Octisalate 5%

Questions Or Comments?

Call (858) 252-0099


Structured Label Content

Warnings

For e xternal 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)

Kopari

Sun Shield Body Glow

Sunscreen SPF 50 DUO

Endless Glow, Applies Clear, Absorbs Seamlessly

Active Ingredients (Active ingredients)

Avobenzone 3%

Homosalate 10%

Octocrylene 10%

Octisalate 5%

Questions Or Comments? (Questions or comments?)

Call (858) 252-0099


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)