FDA.reportPublic FDA data

SUNPROOF NOURISHING LIP BALM Broad Spectrum SPF 24 Sunscreen TANGERINE

Manufacturer
Thrive Causemetics | PhytogenX, Inc.
Effective date
2023-09-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:26:05

Label at a glance#

ProductSUNPROOF NOURISHING LIP BALM Broad Spectrum SPF 24 Sunscreen TANGERINE
Active ingredientAvobenzone, Homosalate, Octisalate
Label structure10 sections

Indications and uses

Helps prevent sunburn If used as directed with other sun protection measures (see Directions ), decreases the risk Skin cancer and early skin aging caused by the sun.

Dosage and administration

For sunscreen use: Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating. Children under 6 months of age: 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 a sunscreen with a Broad Spectrum SPF value of 15 or higher and other su...

Storage and handling

Protect this product from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Avobenzone 3.0%Sunscreen
Homosalate 10.0%Sunscreen
Octisalate 5.0%Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions), decreases the risk Skin cancer and early skin aging caused by the sun.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin.

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

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

For sunscreen use:

  • Apply liberally 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Use a water resistant sunscreen if swimming or sweating.
  • Children under 6 months of age: 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 a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
    • Limit time in the sun, especially from 10 am. - 2 pm.
    • Wear long-sleeved shirts, pants, and sunglasses.

Other information

STORAGE AND HANDLING SECTION

  • Protect this product from excessive heat and direct sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

SYNTHETIC BEESWAX, POLYHYDROXYSTEARIC ACID, THEOBROMA CACAO (COCOA) SEED BUTTER, BUTYROSPERMUM PARKII (SHEA) BUTTER, BUTYLOCTYL SALICYLATE, C32-36 ISOALKYL STEARATE, ALUMINUM STARCH OCTENYLSUCCINATE, BIS-DIGLYCERYL POLYACYLADIPATE-2, BEHENYL BEHENATE, CITRUS AURANTIUM DULCIS (ORANGE) OIL, EUPHORBIA CERIFERA (CANDELILLA) WAX (CANDELILLA CERA), STEARYL BEHENATE, LIMONENE, CETEARYL ALCOHOL, ARGANIA SPINOSA KERNEL OIL, POLYGLYCERYL-3 STEARATE, PUNICA GRANATUM STEROLS, PANTHENOL (VITAMIN B5), SODIUM HYALURONATE, MAGNESIUM ASPARTATE, ZINC GLUCONATE, MANGIFERA INDICA (MANGO) SEED BUTTER, PASSIFLORA INCARNATA SEED OIL, COPPER GLUCONATE, PRUNUS AVIUM (SWEET CHERRY) SEED OIL, POLYSORBATE 60, RICINUS COMMUNIS (CASTOR) SEED OIL, STEVIA REBAUDIANA EXTRACT, HYDROGENATED CASTOR OIL, LINALOOL

SPL UNCLASSIFIED SECTION

Dist. by
Thrive Causemetics, Inc.
Los Angeles, CA 90045

PRINCIPAL DISPLAY PANEL - 8 g Tube Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

bigger
than
beauty™
SKINCARE

SUNPROOF™

NOURISHING
LIP BALM

Solar Shield Technology™

SPF
24

Broad Spectrum
SPF 24 Sunscreen

TANGERINE

NET WT. 0.28 OZ / 8 g

Principal Display Panel - 8 g Tube Box
Principal Display Panel - 8 g Tube Box

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77365-00877365-008-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Name, UNII, Kind table
NameUNIIKind
AvobenzoneG63QQF2NOXACTIB
HomosalateV06SV4M95SACTIB
Octisalate4X49Y0596WACTIB
SYNTHETIC BEESWAX08MNR5YE2RIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
COCOA BUTTER512OYT1CRRIACT
SHEA BUTTERK49155WL9YIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
C32-36 ISOALKYL STEARATETR62N75RCUIACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
BIS-DIGLYCERYL POLYACYLADIPATE-26L246LAM9TIACT
BEHENYL BEHENATEK8NU647RJ0IACT
ORANGE OIL, COLD PRESSEDAKN3KSD11BIACT
CANDELILLA WAXWL0328HX19IACT
STEARYL BEHENATEA68S9UI39DIACT
LIMONENE, (+)-GFD7C86Q1WIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
ARGAN OIL4V59G5UW9XIACT
POLYGLYCERYL-3 STEARATE8FDA8C98S3IACT
PUNICA GRANATUM STEROLSUKV92KC49TIACT
PANTHENOLWV9CM0O67ZIACT
HYALURONATE SODIUMYSE9PPT4THIACT
MAGNESIUM ASPARTATER17X820ROLIACT
ZINC GLUCONATEU6WSN5SQ1ZIACT
MANGIFERA INDICA SEED BUTTER4OXD9M35X2IACT
PASSIFLORA INCARNATA SEED OILS0SU5AC95JIACT
COPPER GLUCONATERV823G6G67IACT
SWEET CHERRY SEED OIL9X3RP3RJFHIACT
POLYSORBATE 60CAL22UVI4MIACT
CASTOR OILD5340Y2I9GIACT
STEVIA REBAUDIUNA LEAF6TC6NN0876IACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
LINALOOL, (+/-)-D81QY6I88EIACT

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
333f4bc6-e0a3-47b2-b7ea-09b98b74654e1af3d475-8976-4f89-91ab-ea9c7e59b1002024-09-17WarningsExact identifier
spl set id: 1af3d475-8976-4f89-91ab-ea9c7e59b100

Reported adverse events (FAERS/openFDA)#

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