Indications and 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.
Hydrating Sheer Lip Balm SPF 30 - DREAM
- Manufacturer
- MDSolarSciences
- Effective date
- 2025-06-05
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 01:02:20
Label at a glance#
ProductHydrating Sheer Lip Balm SPF 30 -Crystal Broad Spectrum SPF 30 UVA-UVB Sunscreen
Active ingredientAVOBENZONE, OCTISALATE, HOMOSALATE
Label structure15 sections
Dosage and administration
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: Limi...
Storage and handling
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
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
| 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 SECTION
- Do not useon damaged or broken skin
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
- 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
SPL UNCLASSIFIED SECTION
DISTRIBUTED BY
MDSOLARSCIENCES CORP.
GREENS FARMS, CT 06838
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 - 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 - 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 - 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 - 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 - 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 - 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
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ebc62596-fc97-4d03-9483-7ba095d25db7 | Product name | 1 | 20151210 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49358-600-01 | Hydrating Sheer Lip Balm SPF 30 -CrystalBroad Spectrum SPF 30 UVA-UVB Sunscreen | 4.2 g in 1 APPLICATOR | LIPSTICK | 4.2 | 2 | |
| 49358-600-01 | Hydrating Sheer Lip Balm SPF 30 -CrystalBroad Spectrum SPF 30 UVA-UVB Sunscreen | 1 in 1 CARTON | LIPSTICK | 1 | 2 | |
| 49358-601-01 | Hydrating Sheer Lip Balm SPF 30 - BAREBroad Spectrum SPF 30 UVA-UVB Sunscreen | 1 in 1 CARTON | LIPSTICK | 1 | 2 | |
| 49358-601-01 | Hydrating Sheer Lip Balm SPF 30 - BAREBroad Spectrum SPF 30 UVA-UVB Sunscreen | 4.2 g in 1 APPLICATOR | LIPSTICK | 4.2 | 2 | |
| 49358-602-01 | Hydrating Sheer Lip Balm SPF 30 - BLUSHBroad Spectrum SPF 30 UVA-UVB Sunscreen | 1 in 1 CARTON | LIPSTICK | 1 | 2 | |
| 49358-602-01 | Hydrating Sheer Lip Balm SPF 30 - BLUSHBroad Spectrum SPF 30 UVA-UVB Sunscreen | 4.2 g in 1 APPLICATOR | LIPSTICK | 4.2 | 2 | |
| 49358-603-01 | Hydrating Sheer Lip Balm SPF 30 - RUBYBroad Spectrum SPF 30 UVA-UVB Sunscreen | 1 in 1 CARTON | LIPSTICK | 1 | 2 | |
| 49358-603-01 | Hydrating Sheer Lip Balm SPF 30 - RUBYBroad Spectrum SPF 30 UVA-UVB Sunscreen | 4.2 g in 1 APPLICATOR | LIPSTICK | 4.2 | 2 | |
| 49358-604-01 | Hydrating Sheer Lip Balm SPF 30 - SHIMMERBroad Spectrum SPF 30 UVA-UVB Sunscreen | 1 in 1 CARTON | LIPSTICK | 1 | 2 | |
| 49358-604-01 | Hydrating Sheer Lip Balm SPF 30 - SHIMMERBroad Spectrum SPF 30 UVA-UVB Sunscreen | 4.2 g in 1 APPLICATOR | LIPSTICK | 4.2 | 2 | |
| 49358-605-01 | Hydrating Sheer Lip Balm SPF 30 - SPICEBroad Spectrum SPF 30 UVA-UVB Sunscreen | 1 in 1 CARTON | LIPSTICK | 1 | 2 | |
| 49358-605-01 | Hydrating Sheer Lip Balm SPF 30 - SPICEBroad Spectrum SPF 30 UVA-UVB Sunscreen | 4.2 g in 1 APPLICATOR | LIPSTICK | 4.2 | 2 | |
| 49358-606-01 | Hydrating Sheer Lip Balm SPF 30 - DREAMBroad Spectrum SPF 30 UVA-UVB Sunscreen | 1 in 1 CARTON | LIPSTICK | 1 | 2 | |
| 49358-606-01 | Hydrating Sheer Lip Balm SPF 30 - DREAMBroad Spectrum SPF 30 UVA-UVB Sunscreen | 4.2 g in 1 APPLICATOR | LIPSTICK | 4.2 | 2 |
Products#
Every source-derived product name is available through these pages.
- Hydrating Sheer Lip Balm SPF 30 -Crystal Broad Spectrum SPF 30 UVA-UVB Sunscreen
- Avobenzone, Octisalate, and Homosalate
- 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
- AVOBENZONE
- OCTISALATE
- HOMOSALATE
- Hydrating Sheer Lip Balm SPF 30 - BARE Broad Spectrum SPF 30 UVA-UVB Sunscreen
- SORBITAN MONOOLEATE
- Hydrating Sheer Lip Balm SPF 30 - BLUSH Broad Spectrum SPF 30 UVA-UVB Sunscreen
- Hydrating Sheer Lip Balm SPF 30 - RUBY Broad Spectrum SPF 30 UVA-UVB Sunscreen
- Hydrating Sheer Lip Balm SPF 30 - SHIMMER Broad Spectrum SPF 30 UVA-UVB Sunscreen
- Hydrating Sheer Lip Balm SPF 30 - SPICE Broad Spectrum SPF 30 UVA-UVB Sunscreen
- TOCOPHEROL
- ASCORBYL PALMITATE
- MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE
- Hydrating Sheer Lip Balm SPF 30 - DREAM Broad Spectrum SPF 30 UVA-UVB Sunscreen
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 49358-600 | 49358-600-01 |
| 49358-601 | 49358-601-01 |
| 49358-602 | 49358-602-01 |
| 49358-603 | 49358-603-01 |
| 49358-604 | 49358-604-01 |
| 49358-605 | 49358-605-01 |
| 49358-606 | 49358-606-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Hydrating Sheer Lip Balm SPF 30 -Crystal Broad Spectrum SPF 30 UVA-UVB Sunscreen | AVOBENZONE, OCTISALATE, AND HOMOSALATE | MDSolarSciences | 0f23441c-2399-4a72-9f0a-420d25db78af | 2025-06-05 | Warnings | 49358-603-01 49358-601-01 49358-606-01 49358-604-01 49358-605-01 49358-602-01 49358-600-01 49358-601 49358-603 49358-605 49358-604 49358-602 49358-606 49358-600 49358060501 49358060601 49358060401 49358060101 49358060001 49358060201 49358060301 36d8ea31-6d00-0d8f-e063-6394a90ae824 0f23441c-2399-4a72-9f0a-420d25db78af |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.