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Drug Facts
DISTRIBUTED BY
MDSOLARSCIENCES CORP.
GREENS FARMS, CT 06838
Hydrating Sheer Lip Balm Spf 30 - Spice Lipstick
FDA Label NDC 49358-605
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Mdsolarsciences for the product Hydrating Sheer Lip Balm Spf 30 - Spice (NDC 49358-605). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - purpose, uses, warnings, otc - do not use, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredients | Purpose |
|---|---|
| Avobenzone 3% | Sunscreen |
| Octisalate 5% | Sunscreen |
| Homosalate 10% | Sunscreen |
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.
Warnings
For external use only
Otc - Do Not Use
- Do not use on damaged or broken skin
Otc - Keep Out Of Reach Of Children
- Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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 - 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)
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)
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)
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)
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
Principal Display Panel (4.2 G Applicator Carton)
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)
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)
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