Sun Voyage Spf Kit

Sun Voyage Spf Kit
SPL v1
SPL
SPL Set ID 2732a8d2-6f56-c088-e063-6294a90af308
Route
TOPICAL
Published
Effective Date 2024-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (10 g) Avobenzone (3 g) Octisalate (5 g) Homosalate (30 mg)
Inactive Ingredients
Octyldodecyl Neopentanoate Farnesol Benzyl Salicylate Levomenol Aloe Vera Leaf Isostearyl Linoleate Linalool, (+)- Octyldodecanol Magnesium Potassium Aluminosilicate Fluoride Coconut Oil Dibutyl Lauroyl Glutamide Sunflower Oil Ginger Citral Butyloctyl Salicylate Ferric Oxide Red Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) Dibutyl Ethylhexanoyl Glutamide .alpha.-hexylcinnamaldehyde Silicon Dioxide Soybean Oil Tocopherol Alkyl (c12-15) Benzoate Glycerin Tert-butyl Alcohol Sodium Benzoate Water .gamma.-decalactone Hexyl Acetate Diisopropyl Adipate Rice Bran Lime Oil, Cold Pressed Triethyl Citrate Alcohol Geranyl Acetate Limonene, (+)- Stannous Oxide Spearmint Oil Bitter Orange Oil Tetrahexyldecyl Ascorbate Hyaluronate Sodium Peg-9 Diglycidyl Ether/sodium Hyaluronate Crosspolymer Dicaprylyl Carbonate 2,6-dimethyl-5-heptenal Citric Acid Monohydrate Propanediol Ethyl Butyrate Litsea Oil Orange Oil, Cold Pressed Hydrogenated Castor Oil Lauryl Lactate Titanium Dioxide Mica Geraniol Castor Oil Dibutyl Maleate Terpineol Polyglutamic Acid (1200 Mw) Maltol Polyamide-3 (12000 Mw) Avocado Oil Kukui Nut Oil .alpha.-tocopherol Acetate Macadamia Oil Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Hibiscus Sabdariffa Seed Oil Linalool, (+/-)-

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-11-01

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 Voyage

SPF Kit

Warnings

For external use only

Directions

• Glide onto body, neck and face 15 minutes before sun exposure for invisible protection.

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 from10 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%

Inactive Ingredients

C12-15 Alkyl Benzoate, Octyldodecanol, Butyloctyl Salicylate, Octyldodecyl Neopentanoate, Isostearyl Linoleate, Dibutyl Lauroyl Glutamide, Polyester-8, Dibutyl Ethylhexanol Glutamide, Silica Silyate, Cocos Nucifera (Coconut) Oil, Tocopherol, Glycine Soja (Soybean) Oil, Bisabolol, Zingiber Officinale (Ginger) Root Extract, Helianthus Annuus (Sunflower) Seed Oil, Aloe Barbadensis Leaf Extract, Fragrance (Parfum), Benzyl Salicylate, Hexyl Cinnamal, Linalool, Synthetic Fluorphlogopite, Silica, Iron Oxides (CI 77489), (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 Voyage

SPF Kit

Purpose

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

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

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

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

Warnings

For external use only

Directions

• Glide onto body, neck and face 15 minutes before sun exposure for invisible protection.

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 from10 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%

Inactive Ingredients

C12-15 Alkyl Benzoate, Octyldodecanol, Butyloctyl Salicylate, Octyldodecyl Neopentanoate, Isostearyl Linoleate, Dibutyl Lauroyl Glutamide, Polyester-8, Dibutyl Ethylhexanol Glutamide, Silica Silyate, Cocos Nucifera (Coconut) Oil, Tocopherol, Glycine Soja (Soybean) Oil, Bisabolol, Zingiber Officinale (Ginger) Root Extract, Helianthus Annuus (Sunflower) Seed Oil, Aloe Barbadensis Leaf Extract, Fragrance (Parfum), Benzyl Salicylate, Hexyl Cinnamal, Linalool, Synthetic Fluorphlogopite, Silica, Iron Oxides (CI 77489), (CI 77491).

Questions Or Comments? (Questions or comments?)

Call (858) 252-0099


Advanced Ingredient Data


Raw Label Data

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