Sunscreen Lip Balm

Sunscreen Lip Balm
SPL v5
SPL
SPL Set ID 0f8e08bf-4b14-bdad-e063-6394a90a34e1
Route
TOPICAL
Published
Effective Date 2024-01-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Polysilicone-15 (5 g) Octocrylene (7 g) Octinoxate (6 g) Homosalate (2 g) Avobenzone (18.91 g)
Inactive Ingredients
Sunflower Oil Polyisobutylene (1000 Mw) Shea Butter Hydrogenated Coconut Oil Rosa Canina Fruit Oil Aloe Arborescens Leaf Ceresin Jojoba Oil Diisostearyl Malate Dicaprylyl Carbonate 1,2-hexanediol Tridecyl Trimellitate Paraffin Microcrystalline Wax Grape Seed Oil Citric Acid Monohydrate Ethylhexyl Palmitate Tocopherol Hydrogenated Polydecene (1500 Cst)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-25

Description

Active ingredients Ethylhexyl Methoxycinnamate 7% Homosalate 6 % Polysilicone-15 5% Octocrylene 5% Butyl Methoxydibenzoylmethane 2%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

helps prevent sumburn

if used as directed with other sun protection measures, (see Directions) decreases therisk of skin cancer and early skin aging caused by the sun

Dosage and Administration

Directions

apply liberally 15 minutes before sun exposure

reapply: after 80 minutes of swimming or sweating

immediately after towel drying at least every 2 hours

children under 6 months of age: ask a doctor Sun Protection Measures. Spendingtime in the sun increases your risk of skin cancer and early skin aging. To decrease thisrisk, regularly use a sunscreen with a Broad Spertrum SPF of 15 or higher

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

wear long-sleeved shirts,pants,hats and sunglasses

Description

Active ingredients Ethylhexyl Methoxycinnamate 7% Homosalate 6 % Polysilicone-15 5% Octocrylene 5% Butyl Methoxydibenzoylmethane 2%

Section 44425-7

Other information protect this product from excessive heat and direct sun

Section 50565-1

Keep out of reach of children. lf swallowed, get medical help or contact a Poison

Control Center immediately.

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 51727-6

lnactive ingredients:Hydrogenated Polydecene, Ethylhexyl Palmitate, Disostearyl Malate.OzokeriteTridecyl Trimellitate, Synthetic Wax, Dicapryly Carbonate, Polyisobutene, Microcrys-talline Wax,Fragrance, Tocopherol, Simmondsia Chinensis (Jojoba) Seed OilHydrogenated Coconut Oil, Butyrospermum Parkii (Shea) Butter, Rosa Canina Fruit Oi.Aloe Barbadensis Extract, Helianthus Annuus (Sunfower) Seed Oil. Vitis ViniferaGrape) Seed Oil,12-Hexanediol, Citric Acid

Section 51945-4

Section 53413-1

Questions or comments?

+1-973-907-6739

Section 55105-1

Sunscreen

Section 55106-9

Active ingredients

Ethylhexyl Methoxycinnamate 7%

Homosalate 6 %

Polysilicone-15 5%

Octocrylene 5%

Butyl Methoxydibenzoylmethane 2%


Structured Label Content

Indications and Usage (34067-9)

helps prevent sumburn

if used as directed with other sun protection measures, (see Directions) decreases therisk of skin cancer and early skin aging caused by the sun

Dosage and Administration (34068-7)

Directions

apply liberally 15 minutes before sun exposure

reapply: after 80 minutes of swimming or sweating

immediately after towel drying at least every 2 hours

children under 6 months of age: ask a doctor Sun Protection Measures. Spendingtime in the sun increases your risk of skin cancer and early skin aging. To decrease thisrisk, regularly use a sunscreen with a Broad Spertrum SPF of 15 or higher

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

wear long-sleeved shirts,pants,hats and sunglasses

Warnings and Precautions (34071-1)

For external use only

Section 44425-7 (44425-7)

Other information protect this product from excessive heat and direct sun

Section 50565-1 (50565-1)

Keep out of reach of children. lf swallowed, get medical help or contact a Poison

Control Center immediately.

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 51727-6 (51727-6)

lnactive ingredients:Hydrogenated Polydecene, Ethylhexyl Palmitate, Disostearyl Malate.OzokeriteTridecyl Trimellitate, Synthetic Wax, Dicapryly Carbonate, Polyisobutene, Microcrys-talline Wax,Fragrance, Tocopherol, Simmondsia Chinensis (Jojoba) Seed OilHydrogenated Coconut Oil, Butyrospermum Parkii (Shea) Butter, Rosa Canina Fruit Oi.Aloe Barbadensis Extract, Helianthus Annuus (Sunfower) Seed Oil. Vitis ViniferaGrape) Seed Oil,12-Hexanediol, Citric Acid

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

+1-973-907-6739

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Active ingredients

Ethylhexyl Methoxycinnamate 7%

Homosalate 6 %

Polysilicone-15 5%

Octocrylene 5%

Butyl Methoxydibenzoylmethane 2%


Advanced Ingredient Data


Raw Label Data

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