Unseen Sunscreen Lip Protector

Unseen Sunscreen Lip Protector
SPL v1
SPL
SPL Set ID 12605fb4-0de6-94f3-e063-6294a90a3a6f
Route
TOPICAL
Published
Effective Date 2024-03-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Octisalate (5 g) Homosalate (9 g) Octocrylene
Inactive Ingredients
Silica Dimethyl Silylate Octyldodecyl Neopentanoate Octyldodecanol Brassica Rapa Var. Rapa Oil Dibutyl Ethylhexanoyl Glutamide Diisostearyl Malate Ricinus Communis Seed Euterpe Oleracea Whole Dibutyl Lauroyl Glutamide Phenethyl Benzoate Saccharin Tocopherol Alkyl (c12-15) Benzoate Dryobalanops Aromatica Whole

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-29

Description

Active Ingredients: Avobenzone 3% Homosalate 9% Octisalate 5% Octocrylene 9%


Medication Information

Warnings and Precautions

For External use only

Do not use on damaged or broken skin

When using this product, keep out of eyes. Rinse with water to remove

Indications and Usage

Stop use and ask a doctor if rash occurs

Dosage and Administration

Directions

Apply generously and evenly 15 minutes before sun exposure

Reapply at least every 2 hours

Use a water resistant sunscreen if swimming or sweating

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

Description

Active Ingredients: Avobenzone 3% Homosalate 9% Octisalate 5% Octocrylene 9%

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 51727-6

Inactive Ingredients: Octyldodecanol, C12-15 Alkyl Benzoate, Ricinus Communis (Castor) Seed Oil, Diisostearyl Malate, Flavor, Dibutyl Lauroyl Glutamide, Phenethyl Benzoate, Dibutyl Ethylhexanoyl Glutamide, Silica Silylate, Brassica Campestris/Aleurites Fordi Oil Crosspolymer, Octyldodecyl Neopentanoate, Saccharin, Tocopherol, Euterpe Oleracea Fruit Oil

Section 51945-4

Unseen Sunscreen Lip Protector SPF 30

Secondary Packaging

Primary Packaging

Section 55105-1

Helps prevent sunburn

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

Section 55106-9

Active Ingredients: Avobenzone 3% Homosalate 9% Octisalate 5% Octocrylene 9%


Structured Label Content

Indications and Usage (34067-9)

Stop use and ask a doctor if rash occurs

Dosage and Administration (34068-7)

Directions

Apply generously and evenly 15 minutes before sun exposure

Reapply at least every 2 hours

Use a water resistant sunscreen if swimming or sweating

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

Warnings and Precautions (34071-1)

For External use only

Do not use on damaged or broken skin

When using this product, keep out of eyes. Rinse with water to remove

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 51727-6 (51727-6)

Inactive Ingredients: Octyldodecanol, C12-15 Alkyl Benzoate, Ricinus Communis (Castor) Seed Oil, Diisostearyl Malate, Flavor, Dibutyl Lauroyl Glutamide, Phenethyl Benzoate, Dibutyl Ethylhexanoyl Glutamide, Silica Silylate, Brassica Campestris/Aleurites Fordi Oil Crosspolymer, Octyldodecyl Neopentanoate, Saccharin, Tocopherol, Euterpe Oleracea Fruit Oil

Section 51945-4 (51945-4)

Unseen Sunscreen Lip Protector SPF 30

Secondary Packaging

Primary Packaging

Section 55105-1 (55105-1)

Helps prevent sunburn

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

Section 55106-9 (55106-9)

Active Ingredients: Avobenzone 3% Homosalate 9% Octisalate 5% Octocrylene 9%


Advanced Ingredient Data


Raw Label Data

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