Image Md Restoring Lip Enhancer Spf15

Image Md Restoring Lip Enhancer Spf15
SPL v2
SPL
SPL Set ID e296579e-ba30-4a29-afe0-bb51f863369c
Route
TOPICAL
Published
Effective Date 2023-11-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (50 g) Avobenzone (30 g) Homosalate (100 g) Octocrylene (40 g)
Inactive Ingredients
Pentaerythrityl Tetraisostearate Ppg-12/smdi Copolymer Ethylhexyl Palmitate Limonene, (+)- Tribehenin Phenyl Trimethicone Sorbitan Isostearate Silica Dimethyl Silylate Butylene Glycol Pentylene Glycol Lactic Acid Linalool, (+)- Sodium Chondroitin Sulfate (porcine; 5500 Mw) Citral Palmitoyl Tripeptide-1 Avocado Oil .alpha.-tocopherol Acetate Tocopherol Hydrogenated Polybutene (1300 Mw) Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Diisopropyl Dilinoleate Oryzanol Ubidecarenone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-03-17

Description

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. Stop use and ask doctor if rash occurs. If swallowed get medical help or contact a Poison Control Center right away.


Medication Information

Description

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. Stop use and ask doctor if rash occurs. If swallowed get medical help or contact a Poison Control Center right away.

Labeling

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. Stop use and ask doctor if rash occurs. If swallowed get medical help or contact a Poison Control Center right away.

Questions

Questions call 800-796-7546

Directions

Apply liberally 15 minutes before sun exposure. Use a water-resistant sunscreen if swimming or sweating. Reapply 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 of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 am to 2 pm. Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: ask a physician.

Other Information

Protect the product in this container from excessive heat and direct sun.

Active Ingredients

Avobenzone   3.0%   Sunscreen

Homosalate   10.0%   Sunscreen

Octisalate   5.0%   Sunscreen

Octocrylene   4.0%   Sunscreen

Indications & Usage

Helps prevent sunburn. If used as directed with other sun protection measure (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Inactive Ingredients

hydrogenated polyisobutene, ethylene/propylene/styrene copolymer, Pentaerythrityl Tetraisostearate, ethylhexyl palmitate, PPG-12/SMDI Copolymer, butylene/ethylene/styrene copolymer, flavor, limonene, tribehenin, phenyl trimethicone, sorbitan isostearate, silican dimethyl silylate, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, butylene glycol, pentylene glycol, lactic acid, linalool, sodium chondrotin sulfate, citral, atelocollagen, palmitoyl tripeptide-1, Avacodo (Persea gratissima) Oil, Diisopropyl Dimer Dilinoleate, Tocopheryl Acetate, Tocopherol, Oryzanol, Ubiquinone.

Keep Out of Reach of Children

Keep out of reach of children


Structured Label Content

Labeling

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. Stop use and ask doctor if rash occurs. If swallowed get medical help or contact a Poison Control Center right away.

Questions

Questions call 800-796-7546

Directions

Apply liberally 15 minutes before sun exposure. Use a water-resistant sunscreen if swimming or sweating. Reapply 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 of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 am to 2 pm. Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: ask a physician.

Other Information (Other information)

Protect the product in this container from excessive heat and direct sun.

Active Ingredients

Avobenzone   3.0%   Sunscreen

Homosalate   10.0%   Sunscreen

Octisalate   5.0%   Sunscreen

Octocrylene   4.0%   Sunscreen

Indications & Usage

Helps prevent sunburn. If used as directed with other sun protection measure (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Inactive Ingredients (Inactive ingredients)

hydrogenated polyisobutene, ethylene/propylene/styrene copolymer, Pentaerythrityl Tetraisostearate, ethylhexyl palmitate, PPG-12/SMDI Copolymer, butylene/ethylene/styrene copolymer, flavor, limonene, tribehenin, phenyl trimethicone, sorbitan isostearate, silican dimethyl silylate, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, butylene glycol, pentylene glycol, lactic acid, linalool, sodium chondrotin sulfate, citral, atelocollagen, palmitoyl tripeptide-1, Avacodo (Persea gratissima) Oil, Diisopropyl Dimer Dilinoleate, Tocopheryl Acetate, Tocopherol, Oryzanol, Ubiquinone.

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children


Advanced Ingredient Data


Raw Label Data

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