Hydrating Sheer Lip Balm Spf 30

Hydrating Sheer Lip Balm Spf 30
SPL v2
SPL
SPL Set ID 0f23441c-2399-4a72-9f0a-420d25db78af
Route
TOPICAL
Published
Effective Date 2023-09-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Octisalate (50 mg) Homosalate (100 mg)
Inactive Ingredients
Avocado Oil Shea Butter Hydrogenated Soybean Oil Paraffin Octyldodecanol Castor Oil Olive Oil Butyloctyl Salicylate Corn Oil Hydrogenated Jojoba Oil, Randomized Stearic Acid Microcrystalline Wax Helianthus Annuus Seed Wax Squalane Tetrahexyldecyl Ascorbate .alpha.-tocopherol Acetate Toxicodendron Vernicifluum Fruit Rind Wax Acacia Decurrens Flower Wax Polyglycerin-3 Sorbitan Monooleate Tocopherol Ascorbyl Palmitate Magnesium Potassium Aluminosilicate Fluoride

Identifiers & Packaging

Pill Appearance
Color: brown Color: pink Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-07-01

Description

Drug Facts


Medication Information

Description

Drug Facts

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.
Section 42229-5

Drug Facts

Section 50565-1
  • Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.
Section 50570-1
  • Do not useon damaged or broken skin
Section 55105-1
Active ingredients Purpose
Avobenzone 3% Sunscreen
Octisalate 5% Sunscreen
Homosalate 10% Sunscreen
Warnings

For external use only

Directions
  • Apply liberally 15 minutes before sun exposure
  • Reapply:
    • use a water resistant sunscreen if swimming or sweating
    • at least every 2 hours
  • 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 the risk, regularly use a sunscreen with Broad Spectrum SPF of 15 or higher and other sun protection measures including:
    • Limit time in the sun, especially from 10a.m.- 2p.m.
    • Wear long-sleeved shirts, pants, hats and sunglasses
Other Information
  • Protect the product in this container from excessive heat and direct sunlight
  • You may report serious adverse reactions to: Report Reaction, LLC., PO Box 22, Plainsboro, NJ 08536-0222
Inactive Ingredients

Persea Gratissima (Avocado) Oil, Butyrospermum Parkii (Shea) Butter, Hydrogenated Soybean Oil, Paraffin, Ricinus Communis (Castor) Seed Oil, Olea Europaea (Olive) Fruit Oil, Octyldodecanol, Butyloctyl Salicylate, Hydrogenated Vegetable Oil, Jojoba Esters, Microcrystalline Wax, Stearic Acid, Helianthus Annuus (Sunflower) Seed Wax, Squalene, Polyglycerin-3, Tetrahexyldecyl Ascorbate (Vitamin C), Tocopheryl Acetate (Vitamin E), Ascorbyl Palmitate (Vitamin C), Tocopherol (Vitamin E), Rhus Verniciflua Peel Wax, Acacia Decurrens Flower Wax, Sorbitan Oleate, Synthetic Fluorphlogopite, May contain: CI 77891, CI 77491, CI 77492, CI 77499, CI 15850, CI 42090, CI 77861, CI 45410, CI 19140

Principal Display Panel 4.2 G Applicator Carton Bare

MDSOLARSCIENCES ®

PROTECT & NOURISH

HYDRATING

SHEER

LIP BALM

Broad Spectrum SPF 30

SPF 30

BARE

SHEA

BUTTER

VITAMIN E

AVOCADO

OIL

VITAMIN C

.15 OZ / 4.2 G

Principal Display Panel 4.2 G Applicator Carton Ruby

MDSOLARSCIENCES ®

PROTECT & NOURISH

HYDRATING

SHEER

LIP BALM

Broad Spectrum SPF 30

SPF 30

RUBY

SHEA

BUTTER

VITAMIN E

AVOCADO

OIL

VITAMIN C

.15 OZ / 4.2 G

Principal Display Panel 4.2 G Applicator Carton Blush

MDSOLARSCIENCES ®

PROTECT & NOURISH

HYDRATING

SHEER

LIP BALM

Broad Spectrum SPF 30

SPF 30

BLUSH

SHEA

BUTTER

VITAMIN E

AVOCADO

OIL

VITAMIN C

.15 OZ / 4.2 G

Principal Display Panel 4.2 G Applicator Carton Dream

MDSOLARSCIENCES ®

PROTECT & NOURISH

HYDRATING

SHEER

LIP BALM

Broad Spectrum SPF 30

SPF 30

DREAM

SHEA

BUTTER

VITAMIN E

AVOCADO

OIL

VITAMIN C

.15 OZ / 4.2 G

Principal Display Panel 4.2 G Applicator Carton Spice

MDSOLARSCIENCES ®

PROTECT & NOURISH

HYDRATING

SHEER

LIP BALM

Broad Spectrum SPF 30

SPF 30

SPICE

SHEA

BUTTER

VITAMIN E

AVOCADO

OIL

VITAMIN C

.15 OZ / 4.2 G

Principal Display Panel 4.2 G Applicator Carton Crystal

MDSOLARSCIENCES ®

HYDRATING

SHEER

LIP BALM

Broad Spectrum SPF 30

SPF 30

CRYSTAL

DERMATOLOGIST

DEVELOPED

SHEA

BUTTER

VITAMIN E

AVOCADO

OIL

VITAMIN C

.15 OZ / 4.2 G

Principal Display Panel 4.2 G Applicator Carton Shimmer

MDSOLARSCIENCES ®

PROTECT & NOURISH

HYDRATING

SHEER

LIP BALM

Broad Spectrum SPF 30

SPF 30

SHIMMER

SHEA

BUTTER

VITAMIN E

AVOCADO

OIL

VITAMIN C

.15 OZ / 4.2 G


Structured Label Content

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.
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)
  • Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.
Section 50570-1 (50570-1)
  • Do not useon damaged or broken skin
Section 55105-1 (55105-1)
Active ingredients Purpose
Avobenzone 3% Sunscreen
Octisalate 5% Sunscreen
Homosalate 10% Sunscreen
Warnings

For external use only

Directions
  • Apply liberally 15 minutes before sun exposure
  • Reapply:
    • use a water resistant sunscreen if swimming or sweating
    • at least every 2 hours
  • 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 the risk, regularly use a sunscreen with Broad Spectrum SPF of 15 or higher and other sun protection measures including:
    • Limit time in the sun, especially from 10a.m.- 2p.m.
    • Wear long-sleeved shirts, pants, hats and sunglasses
Other Information
  • Protect the product in this container from excessive heat and direct sunlight
  • You may report serious adverse reactions to: Report Reaction, LLC., PO Box 22, Plainsboro, NJ 08536-0222
Inactive Ingredients

Persea Gratissima (Avocado) Oil, Butyrospermum Parkii (Shea) Butter, Hydrogenated Soybean Oil, Paraffin, Ricinus Communis (Castor) Seed Oil, Olea Europaea (Olive) Fruit Oil, Octyldodecanol, Butyloctyl Salicylate, Hydrogenated Vegetable Oil, Jojoba Esters, Microcrystalline Wax, Stearic Acid, Helianthus Annuus (Sunflower) Seed Wax, Squalene, Polyglycerin-3, Tetrahexyldecyl Ascorbate (Vitamin C), Tocopheryl Acetate (Vitamin E), Ascorbyl Palmitate (Vitamin C), Tocopherol (Vitamin E), Rhus Verniciflua Peel Wax, Acacia Decurrens Flower Wax, Sorbitan Oleate, Synthetic Fluorphlogopite, May contain: CI 77891, CI 77491, CI 77492, CI 77499, CI 15850, CI 42090, CI 77861, CI 45410, CI 19140

Principal Display Panel 4.2 G Applicator Carton Bare (PRINCIPAL DISPLAY PANEL - 4.2 G Applicator Carton - Bare)

MDSOLARSCIENCES ®

PROTECT & NOURISH

HYDRATING

SHEER

LIP BALM

Broad Spectrum SPF 30

SPF 30

BARE

SHEA

BUTTER

VITAMIN E

AVOCADO

OIL

VITAMIN C

.15 OZ / 4.2 G

Principal Display Panel 4.2 G Applicator Carton Ruby (PRINCIPAL DISPLAY PANEL - 4.2 G Applicator Carton - Ruby)

MDSOLARSCIENCES ®

PROTECT & NOURISH

HYDRATING

SHEER

LIP BALM

Broad Spectrum SPF 30

SPF 30

RUBY

SHEA

BUTTER

VITAMIN E

AVOCADO

OIL

VITAMIN C

.15 OZ / 4.2 G

Principal Display Panel 4.2 G Applicator Carton Blush (PRINCIPAL DISPLAY PANEL - 4.2 G Applicator Carton - Blush)

MDSOLARSCIENCES ®

PROTECT & NOURISH

HYDRATING

SHEER

LIP BALM

Broad Spectrum SPF 30

SPF 30

BLUSH

SHEA

BUTTER

VITAMIN E

AVOCADO

OIL

VITAMIN C

.15 OZ / 4.2 G

Principal Display Panel 4.2 G Applicator Carton Dream (PRINCIPAL DISPLAY PANEL - 4.2 G Applicator Carton - Dream)

MDSOLARSCIENCES ®

PROTECT & NOURISH

HYDRATING

SHEER

LIP BALM

Broad Spectrum SPF 30

SPF 30

DREAM

SHEA

BUTTER

VITAMIN E

AVOCADO

OIL

VITAMIN C

.15 OZ / 4.2 G

Principal Display Panel 4.2 G Applicator Carton Spice (PRINCIPAL DISPLAY PANEL - 4.2 G Applicator Carton - Spice)

MDSOLARSCIENCES ®

PROTECT & NOURISH

HYDRATING

SHEER

LIP BALM

Broad Spectrum SPF 30

SPF 30

SPICE

SHEA

BUTTER

VITAMIN E

AVOCADO

OIL

VITAMIN C

.15 OZ / 4.2 G

Principal Display Panel 4.2 G Applicator Carton Crystal (PRINCIPAL DISPLAY PANEL - 4.2 G Applicator Carton - Crystal)

MDSOLARSCIENCES ®

HYDRATING

SHEER

LIP BALM

Broad Spectrum SPF 30

SPF 30

CRYSTAL

DERMATOLOGIST

DEVELOPED

SHEA

BUTTER

VITAMIN E

AVOCADO

OIL

VITAMIN C

.15 OZ / 4.2 G

Principal Display Panel 4.2 G Applicator Carton Shimmer (PRINCIPAL DISPLAY PANEL - 4.2 G Applicator Carton - Shimmer)

MDSOLARSCIENCES ®

PROTECT & NOURISH

HYDRATING

SHEER

LIP BALM

Broad Spectrum SPF 30

SPF 30

SHIMMER

SHEA

BUTTER

VITAMIN E

AVOCADO

OIL

VITAMIN C

.15 OZ / 4.2 G


Advanced Ingredient Data


Raw Label Data

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