Lip Renewal Spf 50

Lip Renewal Spf 50
SPL v1
SPL
SPL Set ID 187cd4ad-781f-b0e4-e063-6394a90a414b
Route
TOPICAL
Published
Effective Date 2024-06-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (1.05 g) Avobenzone (0.42 g) Homosalate (1.4 g) Octisalate (0.7 g)
Inactive Ingredients
Phenoxyethanol Hyaluronic Acid Water Limonene, (+)- Menthol Vanillin Lycium Barbarum Fruit Glyceryl Diisostearate Dimethicone Grape Seed Oil Diisostearyl Malate Spearmint Oil Carvone, (+/-)- Triisostearin Tocopherol Aspalathus Linearis Leaf Leuconostoc/radish Root Ferment Filtrate Glycerin Citral Microcrystalline Wax Shea Butter Punica Granatum Root Bark Allantoin Green Tea Leaf Jojoba Oil Carnauba Wax Squalane Vitis Vinifera Seed

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-12-09
Description

Active Ingredients Avobenzone...........................3.0% Homosalate...........................10.0% Octinoxate.............................7.5% Octisalate..............................5.0%

Medication Information

Warnings and Precautions

Warnings

For External use only

Indications and Usage

Uses

  • 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
Dosage and Administration

Directions

  • Apply liberally and evenly every 15 minutes before sun exposure
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating
  • Children under 6 months: Ask a doctor
  • Sun Protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use as sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including:
  • limit time in the sun especially from 10am -2 pm.
  • wear long sleeve shirt, pants hats and sunglasses
Description

Active Ingredients Avobenzone...........................3.0% Homosalate...........................10.0% Octinoxate.............................7.5% Octisalate..............................5.0%

Section 50565-1

Keep out of reach of children.

If product is swallowed, get madical help or contact a poison control center right away.

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

Inactive Ingredients

Microcrystalline Wax, Diisostearyl Malate, Glyceryl Diisostearate, Simmondsia Chinensis (Jojoba) Seed Oil, Copernicia Cerifera (Carnauba) Wax, Butyrospermum Parkii (Shea) Butter, Dimethicone, Glycerin, Vitis Vinifera (Grape) Seed Oil, Flavor (Aroma), Triisostearin, Tocopherol, Squalane, Lycium Barbarum Fruit Extract, Punica Granatum Extract, Vitis Vinifera (Grape) Seed Extract, Aspalathus Linearis Leaf Extract, Allantoin, Water/ Aqua, Leuconostoc/Radish Root Ferment Filtrate, Camellia Sinensis Leaf Extract, Hyaluronic Acid, Phenoxyethanol, Limonene, Citral

Section 51945-4

Section 53413-1

Questions or comments?

Call toll free 1-866-JUNEJACOBS

  • www.JUNEJACOBS.com
Section 55105-1

Sunscreen

Section 55106-9

Active Ingredients

Avobenzone...........................3.0%

Homosalate...........................10.0%

Octinoxate.............................7.5%

Octisalate..............................5.0%

Section 60561-8

Other Information

  • Protect this product from excessive heat and direct sun.

Structured Label Content

Indications and Usage (34067-9)

Uses

  • 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
Dosage and Administration (34068-7)

Directions

  • Apply liberally and evenly every 15 minutes before sun exposure
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating
  • Children under 6 months: Ask a doctor
  • Sun Protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use as sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including:
  • limit time in the sun especially from 10am -2 pm.
  • wear long sleeve shirt, pants hats and sunglasses
Warnings and Precautions (34071-1)

Warnings

For External use only

Section 50565-1 (50565-1)

Keep out of reach of children.

If product is swallowed, get madical help or contact a poison control center right away.

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)

Inactive Ingredients

Microcrystalline Wax, Diisostearyl Malate, Glyceryl Diisostearate, Simmondsia Chinensis (Jojoba) Seed Oil, Copernicia Cerifera (Carnauba) Wax, Butyrospermum Parkii (Shea) Butter, Dimethicone, Glycerin, Vitis Vinifera (Grape) Seed Oil, Flavor (Aroma), Triisostearin, Tocopherol, Squalane, Lycium Barbarum Fruit Extract, Punica Granatum Extract, Vitis Vinifera (Grape) Seed Extract, Aspalathus Linearis Leaf Extract, Allantoin, Water/ Aqua, Leuconostoc/Radish Root Ferment Filtrate, Camellia Sinensis Leaf Extract, Hyaluronic Acid, Phenoxyethanol, Limonene, Citral

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

Call toll free 1-866-JUNEJACOBS

  • www.JUNEJACOBS.com
Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Active Ingredients

Avobenzone...........................3.0%

Homosalate...........................10.0%

Octinoxate.............................7.5%

Octisalate..............................5.0%

Section 60561-8 (60561-8)

Other Information

  • Protect this product from excessive heat and direct sun.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:09.538643 · Updated: 2026-03-14T23:03:04.544899