Hydrating Lip Balm Spf 15 Sunscreen

Hydrating Lip Balm Spf 15 Sunscreen
SPL v1
SPL
SPL Set ID bafadc36-5019-4f18-a4fd-85f8d4a70053
Route
TOPICAL
Published
Effective Date 2014-08-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3.5 g) Homosalate (5.0 g) Octocrylene Octisalate
Inactive Ingredients
Hydrogenated Polybutene (1300 Mw) Niacinamide Tricaprylin Ethyl Macadamiate .alpha.-bisabolol, (+)- Tocopherol Ginger Malic Acid Mandarin Oil Grapefruit Oil Bergamot Oil Lemon Oil Ethyl Methylphenylglycidate Butylated Hydroxytoluene Limonene, (+)-

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-08-07

Description

Active Ingredients        Purpose Avobenzone 3.5%        Sunscreen Homosalate 5.0%         Sunscreen Octocrylene 5.0%         Sunscreen       Octisalate 5.0%            Sunscreen


Medication Information

Warnings and Precautions

Warnings:

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 Liberally to lips as often as desired

Apply liberally 15 minutes before sun exposure

Reapply: at least every 2 hours

Use a water resistant sunscreen if swimming or sweating

Sun Protectection 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 15 or higher and other skin protection measures including:

- Limit time in the sun especially from 10 a.m. -2 p.m.

- Wear long-sleeve shirts, pants, and sunglasses

- Children under 6 months ask a doctor

Description

Active Ingredients        Purpose Avobenzone 3.5%        Sunscreen Homosalate 5.0%         Sunscreen Octocrylene 5.0%         Sunscreen       Octisalate 5.0%            Sunscreen

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

Hydrogenated Polysiobutene, Ethylene/Propylene/Styrene Copolymer, Nicinamide, Rohododendron Ferruineum (Alpine Rose) Extract, Tricaprylin, Polyamide-3, Ethyl Macadamiate, Bisabolol, Tocopherol, Zingiber Officinale (Ginger) Root Extract, Glycerin, Malic Acid, Citrus Reticulata (Tangerine) Peel Oil, Citrus Paradisi (Grapefruit) Peel Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Medica Limonium (Lemon) peel Oil, Ethyl Methylphenylglycidate, Butylene/Ethylene/Styrene Copolymer, BHT,limonene.

Section 51945-4

asap

the science of beautiful

hydrating lip balm+

with niacinamide +Alpine Rose

protect

SPF 15 SUNSCREEN

10mL/0.34floz

Section 55105-1

Uses: Helps prevent sunburn and chapped lips. 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        Purpose



Avobenzone 3.5%        Sunscreen

Homosalate 5.0%         Sunscreen

Octocrylene 5.0%         Sunscreen      

Octisalate 5.0%            Sunscreen


Structured Label Content

Indications and Usage (34067-9)

Stop use and ask a doctor if rash occurs.

Dosage and Administration (34068-7)

Directions

Apply Liberally to lips as often as desired

Apply liberally 15 minutes before sun exposure

Reapply: at least every 2 hours

Use a water resistant sunscreen if swimming or sweating

Sun Protectection 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 15 or higher and other skin protection measures including:

- Limit time in the sun especially from 10 a.m. -2 p.m.

- Wear long-sleeve shirts, pants, and sunglasses

- Children under 6 months ask a doctor

Warnings and Precautions (34071-1)

Warnings:

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)

Hydrogenated Polysiobutene, Ethylene/Propylene/Styrene Copolymer, Nicinamide, Rohododendron Ferruineum (Alpine Rose) Extract, Tricaprylin, Polyamide-3, Ethyl Macadamiate, Bisabolol, Tocopherol, Zingiber Officinale (Ginger) Root Extract, Glycerin, Malic Acid, Citrus Reticulata (Tangerine) Peel Oil, Citrus Paradisi (Grapefruit) Peel Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Medica Limonium (Lemon) peel Oil, Ethyl Methylphenylglycidate, Butylene/Ethylene/Styrene Copolymer, BHT,limonene.

Section 51945-4 (51945-4)

asap

the science of beautiful

hydrating lip balm+

with niacinamide +Alpine Rose

protect

SPF 15 SUNSCREEN

10mL/0.34floz

Section 55105-1 (55105-1)

Uses: Helps prevent sunburn and chapped lips. 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        Purpose



Avobenzone 3.5%        Sunscreen

Homosalate 5.0%         Sunscreen

Octocrylene 5.0%         Sunscreen      

Octisalate 5.0%            Sunscreen


Advanced Ingredient Data


Raw Label Data

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