FDA.reportPublic FDA data

Hydrating Sheer Lip Balm SPF 30 - Nude

Manufacturer
MDSolarSciences
Effective date
2019-08-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:00:39

Label at a glance#

ProductHydrating Sheer Lip Balm SPF 30 - Red Broad Spectrum SPF 30 UVA-UVB Sunscreen
Active ingredientAvobenzone, Octisalate, Homosalate
Label structure11 sections

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.

Dosage and administration

Apply liberally 15 minutes before sun exposure & again after swimming or sweating. Reapply at least every 2 hours. Children under 6 months: Ask a doctor Sun Protection Measures: To decrease your risk of skin cancer and early skin aging, regularly use a sunscreen of SPF15 or higher and other sun protective measures including: Limit time in the sun, especially from 10a.m. - 2p.m. Wear long-sleeved shirts, pants, hat...

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 IngredientsPurpose
Avobenzone 2%Sunscreen
Octisalate 5%Sunscreen
Homosalate 10%Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

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

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure & again after swimming or sweating.
  • Reapply at least every 2 hours.
  • Children under 6 months: Ask a doctor
  • Sun Protection Measures: To decrease your risk of skin cancer and early skin aging, regularly use a sunscreen of SPF15 or higher and other sun protective measures including:
    • Limit time in the sun, especially from 10a.m. - 2p.m.
    • Wear long-sleeved shirts, pants, hats and sunglasses

Other Information

STORAGE AND HANDLING SECTION

  • 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

INACTIVE INGREDIENT SECTION

Persea Gratissima (Avocado) Oil, Butyrospermum Parkii (Shea) Butter, Paraffin Wax, Hydrogenated Soybean Oil, Ricinus Communis (Castor) Seed Oil, Octyldodecanol, Olea Europaea (Olive) Fruit Oil, Jojoba Esters, Hydrogenated Vegetable Oil, Microcrystalline Wax, Stearic Acid, Helianthus Annuus (Sunflower) Seed Oil, Squalane, Acacia Decurrens Flower Wax, Polyglycerin-3, Rhus Verniciflua Peel Wax, Sorbitan Oleate, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Ascorbyl Palmitate, Tocopherol. May contain: Titanium Dioxide (CI 77891), Iron Oxides (CI 77491- Red), Iron Oxides (CI 77492 - Yellow), Iron Oxides (CI 77499 - Black) CI 19140 - Yellow 5, Red 28 Lake (CI 45410)

SPL UNCLASSIFIED SECTION

Distributed by: MDSolarSciences Corp, Stamford, CT 06902

PRINCIPAL DISPLAY PANEL - 4.2 g Applicator Carton - Nude

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NUDE

MDSolarSciences™

HYDRATING
SHEER
LIP BALM

30

BROAD SPECTRUM
SPF 30
UVA-UVB SUNSCREEN

sun repair

Net Wt. 4.2 g -.15Oz

PRINCIPAL DISPLAY PANEL - 4.2 g Applicator Carton - Nude
PRINCIPAL DISPLAY PANEL - 4.2 g Applicator Carton - Nude

PRINCIPAL DISPLAY PANEL - 4.2 g Applicator Carton - Pink

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PINK

MDSolarSciences™

HYDRATING
SHEER
LIP BALM

30

BROAD SPECTRUM
SPF 30
UVA-UVB SUNSCREEN

sun repair

Net Wt. 4.2 g -.15Oz

PRINCIPAL DISPLAY PANEL - 4.2 g Applicator Carton - Pink
PRINCIPAL DISPLAY PANEL - 4.2 g Applicator Carton - Pink

PRINCIPAL DISPLAY PANEL - 4.2 g Applicator Carton - Red

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RED

MDSolarSciences™

HYDRATING
SHEER
LIP BALM

30

BROAD SPECTRUM
SPF 30
UVA-UVB SUNSCREEN

sun repair

Net Wt. 4.2 g -.15Oz

PRINCIPAL DISPLAY PANEL - 4.2 g Applicator Carton - Red
PRINCIPAL DISPLAY PANEL - 4.2 g Applicator Carton - Red

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49358-564-012023-01-30C16284748780-1f386c649-fe43-0266-e053-dadaa90a7c1aHydrating Sheer Lip Balm SPF 30 Broad Spectrum SPF 30 UVA-UVB Sunscreen
49358-565-012023-01-30C16284748780-1f386c649-fe43-0266-e053-dadaa90a7c1aHydrating Sheer Lip Balm SPF 30 Broad Spectrum SPF 30 UVA-UVB Sunscreen
49358-566-012023-01-30C16284748780-1f386c649-fe43-0266-e053-dadaa90a7c1aHydrating Sheer Lip Balm SPF 30 Broad Spectrum SPF 30 UVA-UVB Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49358-564-01Hydrating Sheer Lip Balm SPF 30 - Red Broad Spectrum SPF 30 UVA-UVB Sunscreen1 in 1 CARTONLIPSTICK11
49358-564-01Hydrating Sheer Lip Balm SPF 30 - Red Broad Spectrum SPF 30 UVA-UVB Sunscreen4.2 g in 1 APPLICATORLIPSTICK4.21
49358-565-01Hydrating Sheer Lip Balm SPF 30 - Pink Broad Spectrum SPF 30 UVA-UVB Sunscreen4.2 g in 1 APPLICATORLIPSTICK4.21
49358-565-01Hydrating Sheer Lip Balm SPF 30 - Pink Broad Spectrum SPF 30 UVA-UVB Sunscreen1 in 1 CARTONLIPSTICK11
49358-566-01Hydrating Sheer Lip Balm SPF 30 - Nude Broad Spectrum SPF 30 UVA-UVB Sunscreen1 in 1 CARTONLIPSTICK11
49358-566-01Hydrating Sheer Lip Balm SPF 30 - Nude Broad Spectrum SPF 30 UVA-UVB Sunscreen4.2 g in 1 APPLICATORLIPSTICK4.21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49358-564HYDRATING SHEER LIP BALM SPF 30 - RED BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN (AVOBENZONE, OCTISALATE, AND HOMOSALATE) LIPSTICK HYDRATING SHEER LIP BALM SPF 30 - PINK BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN (AVOBENZONE, OCTISALATE, AND HOMOSALATE) LIPSTICK HYDRATING SHEER LIP BALM SPF 30 - NUDE BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN (AVOBENZONE, OCTISALATE, AND HOMOSALATE) LIPSTICK [MDSOLARSCIENCES]1Legacy NDC, 2 package rows20191001_b32317c2-8c78-4f89-81a3-b4e524a04833.zip
49358-565HYDRATING SHEER LIP BALM SPF 30 - RED BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN (AVOBENZONE, OCTISALATE, AND HOMOSALATE) LIPSTICK HYDRATING SHEER LIP BALM SPF 30 - PINK BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN (AVOBENZONE, OCTISALATE, AND HOMOSALATE) LIPSTICK HYDRATING SHEER LIP BALM SPF 30 - NUDE BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN (AVOBENZONE, OCTISALATE, AND HOMOSALATE) LIPSTICK [MDSOLARSCIENCES]1Legacy NDC, 2 package rows20191001_b32317c2-8c78-4f89-81a3-b4e524a04833.zip
49358-566HYDRATING SHEER LIP BALM SPF 30 - RED BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN (AVOBENZONE, OCTISALATE, AND HOMOSALATE) LIPSTICK HYDRATING SHEER LIP BALM SPF 30 - PINK BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN (AVOBENZONE, OCTISALATE, AND HOMOSALATE) LIPSTICK HYDRATING SHEER LIP BALM SPF 30 - NUDE BROAD SPECTRUM SPF 30 UVA-UVB SUNSCREEN (AVOBENZONE, OCTISALATE, AND HOMOSALATE) LIPSTICK [MDSOLARSCIENCES]1Legacy NDC, 2 package rows20191001_b32317c2-8c78-4f89-81a3-b4e524a04833.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49358-56449358-564-01
49358-56549358-565-01
49358-56649358-566-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 3 · 90 matching rows.

Name, UNII, Kind table
NameUNIIKind
AvobenzoneG63QQF2NOXACTIB
Octisalate4X49Y0596WACTIB
HomosalateV06SV4M95SACTIB
Avocado Oil6VNO72PFC1IACT
Shea ButterK49155WL9YIACT
PARAFFINI9O0E3H2ZEIACT
HYDROGENATED SOYBEAN OILA2M91M918CIACT
Castor OilD5340Y2I9GIACT
OCTYLDODECANOL461N1O614YIACT
OLIVE OIL6UYK2W1W1EIACT
HYDROGENATED JOJOBA OIL, RANDOMIZEDQ47ST02F58IACT
CORN OIL8470G57WFMIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
STEARIC ACID4ELV7Z65APIACT
SUNFLOWER OIL3W1JG795YIIACT
SQUALANEGW89575KF9IACT
ACACIA DECURRENS FLOWER WAXAU6XZE9IY9IACT
POLYGLYCERIN-34A0NCJ6RD6IACT
TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX6RG2461FCHIACT
SORBITAN MONOOLEATE06XEA2VD56IACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ASCORBYL PALMITATEQN83US2B0NIACT
TOCOPHEROLR0ZB2556P8IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
FD&C YELLOW NO. 5I753WB2F1MIACT
D&C RED NO. 28767IP0Y5NHIACT
AvobenzoneG63QQF2NOXACTIB
Octisalate4X49Y0596WACTIB
HomosalateV06SV4M95SACTIB
Avocado Oil6VNO72PFC1IACT
Shea ButterK49155WL9YIACT
PARAFFINI9O0E3H2ZEIACT
HYDROGENATED SOYBEAN OILA2M91M918CIACT
Castor OilD5340Y2I9GIACT
OCTYLDODECANOL461N1O614YIACT
OLIVE OIL6UYK2W1W1EIACT

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
313f1a49-3cc4-4492-a948-7470b139c537b32317c2-8c78-4f89-81a3-b4e524a048332019-08-06WarningsExact identifier
spl id: 313f1a49-3cc4-4492-a948-7470b139c537
spl set id: b32317c2-8c78-4f89-81a3-b4e524a04833

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.