Sunscreen Lip Protectionbroad Spectrum Spf 15

Sunscreen Lip Protectionbroad Spectrum Spf 15
SPL v4
SPL
SPL Set ID 1c32b019-a038-eb61-e063-6394a90a45f2
Route
TOPICAL
Published
Effective Date 2024-07-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (7.5 mg) Octocrylene (5 mg)
Inactive Ingredients
Icodextrin Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Cocoa Yellow Wax Petrolatum Phenoxyethanol Microcrystalline Wax Tocopherol Ethylhexylglycerin Ethylhexyl Palmitate Styrene/isoprene Copolymer (28:72; 210000 Mw) Polyisobutylene (1000 Mw) Phytosteryl/octyldodecyl Lauroyl Glutamate .alpha.-tocopherol Acetate Tridecyl Trimellitate Jojoba Oil Shea Butter Fd&c Yellow No. 5 Synthetic Wax (1200 Mw) Macadamia Oil Hydrogenated Coconut Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-02

Description

Ethylhexyl Methoxycinnamate 7.5% Octocrylene 5%


Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

protect lips from damaging UVA and UVB rays.

Dosage and Administration

Step 1:Saueeze tube.

Step 2:Apply liberally and evenly to lips 15 to 20 minutes before exposure to the sun.

Step3:Reapply after periods of swimming exercise and towel drying or as required.

Description

Ethylhexyl Methoxycinnamate 7.5% Octocrylene 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 51727-6

Ethylhexyl Palmitate, Polyisobutene,Petrolatum,Microcrystalline Wax,Hydrogenated Styrene/lsoprene Copolymer,PentaerythritylTetra-Di-T-ButylHydroxyhydrocinnamate,Beeswax, Synthetic Wax, Tocopheryl Acetate, Tridecyl Trimellitate,Simmondsia Chinensis (Jojoba) Seed Oil,Macadamia Integrifolia Seed Oil, Limnanthes Alba(Meadowfoam)Seed Oi,Butyrospermum Parkii (Shea) Butter, Hydrogenated Coconut Oil,Phenoxyethanol,Ethylhexylglycerin,Fragrance,FD&C YELLOW NO.5(C119140),TheobromaCacao(Cocoa)Extract,

Dextrin,Phytosteryl/OctyldodecylLauroyl, Glutamate,Tocopherol

Section 51945-4

Section 53413-1

You can email us at [email protected] for more help!

Section 55105-1

Sunscreen

Section 55106-9

Ethylhexyl Methoxycinnamate 7.5%

Octocrylene 5%

Section 60561-8

Protect this product from excessive heat anddirect sun.

Sun alert: Limiting sun exposure, wearing protective clothing,and using sunscreens may reduce the risk of skin aging, skin cancer,and other harmful effects of the sun.


Structured Label Content

Indications and Usage (34067-9)

protect lips from damaging UVA and UVB rays.

Dosage and Administration (34068-7)

Step 1:Saueeze tube.

Step 2:Apply liberally and evenly to lips 15 to 20 minutes before exposure to the sun.

Step3:Reapply after periods of swimming exercise and towel drying or as required.

Warnings and Precautions (34071-1)

For external use only.

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 51727-6 (51727-6)

Ethylhexyl Palmitate, Polyisobutene,Petrolatum,Microcrystalline Wax,Hydrogenated Styrene/lsoprene Copolymer,PentaerythritylTetra-Di-T-ButylHydroxyhydrocinnamate,Beeswax, Synthetic Wax, Tocopheryl Acetate, Tridecyl Trimellitate,Simmondsia Chinensis (Jojoba) Seed Oil,Macadamia Integrifolia Seed Oil, Limnanthes Alba(Meadowfoam)Seed Oi,Butyrospermum Parkii (Shea) Butter, Hydrogenated Coconut Oil,Phenoxyethanol,Ethylhexylglycerin,Fragrance,FD&C YELLOW NO.5(C119140),TheobromaCacao(Cocoa)Extract,

Dextrin,Phytosteryl/OctyldodecylLauroyl, Glutamate,Tocopherol

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

You can email us at [email protected] for more help!

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Ethylhexyl Methoxycinnamate 7.5%

Octocrylene 5%

Section 60561-8 (60561-8)

Protect this product from excessive heat anddirect sun.

Sun alert: Limiting sun exposure, wearing protective clothing,and using sunscreens may reduce the risk of skin aging, skin cancer,and other harmful effects of the sun.


Advanced Ingredient Data


Raw Label Data

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