SUNPROOF™ INTENSIVE LIP BALM Broad Spectrum SPF 24 Sunscreen FRESH MINT

SUNPROOF INTENSIVE LIP BALM Broad Spectrum SPF 24 Sunscreen FRESH MINT by

Drug Labeling and Warnings

SUNPROOF INTENSIVE LIP BALM Broad Spectrum SPF 24 Sunscreen FRESH MINT by is a Otc medication manufactured, distributed, or labeled by Thrive Causemetics, PhytogenX, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SUNPROOF INTENSIVE LIP BALM BROAD SPECTRUM SPF 24 SUNSCREEN FRESH MINT- avobenzone, homosalate, and octisalate lipstick 
Thrive Causemetics

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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SUNPROOF™ INTENSIVE LIP BALM Broad Spectrum SPF 24 Sunscreen FRESH MINT

Drug Facts

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

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.

Warnings

For external use only.

Do not use

  • on damaged or broken skin.

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

Stop use and ask a doctor if rash occurs.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

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

  • Protect this product from excessive heat and direct sun.

Inactive ingredients

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, MENTHA PIPERITA (PEPPERMINT) OIL, EUPHORBIA CERIFERA (CANDELILLA) WAX (CANDELILLA CERA), STEARYL BEHENATE, CETEARYL ALCOHOL, PUNICA GRANATUM STEROLS, ARGANIA SPINOSA KERNEL OIL, POLYGLYCERYL-3 STEARATE, MENTHA VIRIDIS (SPEARMINT) LEAF OIL, PIMPINELLA ANISUM (ANISE) SEED OIL, 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, LIMONENE

Questions?

Call (888) 804-4318 or visit www.thrivecausemetics.com

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

PRINCIPAL DISPLAY PANEL - 8 g Tube Box

thrive™
causemetics

SUNPROOF™
INTENSIVE LIP BALM

Hydro Mask Matrix™

SPF
24

Broad Spectrum
SPF 24 Sunscreen

NET WT.
0.28 Oz / 8 g

PRINCIPAL DISPLAY PANEL - 8 g Tube Box
SUNPROOF INTENSIVE LIP BALM BROAD SPECTRUM SPF 24 SUNSCREEN FRESH MINT 
avobenzone, homosalate, and octisalate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 77365-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone30 mg  in 1 g
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate100 mg  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
COCOA BUTTER (UNII: 512OYT1CRR)  
SHEA BUTTER (UNII: K49155WL9Y)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
BEHENYL BEHENATE (UNII: K8NU647RJ0)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
CANDELILLA WAX (UNII: WL0328HX19)  
STEARYL BEHENATE (UNII: A68S9UI39D)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
ARGAN OIL (UNII: 4V59G5UW9X)  
SPEARMINT OIL (UNII: C3M81465G5)  
ANISE OIL (UNII: 6Y89129C8H)  
PANTHENOL (UNII: WV9CM0O67Z)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
MAGNESIUM ASPARTATE (UNII: R17X820ROL)  
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
PASSIFLORA INCARNATA SEED OIL (UNII: S0SU5AC95J)  
COPPER GLUCONATE (UNII: RV823G6G67)  
SWEET CHERRY SEED OIL (UNII: 9X3RP3RJFH)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
CASTOR OIL (UNII: D5340Y2I9G)  
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
Product Characteristics
ColorYELLOWScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 77365-002-011 in 1 BOX05/12/202104/19/2023
18 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35205/12/202104/19/2023
Labeler - Thrive Causemetics (039299574)
Establishment
NameAddressID/FEIBusiness Operations
PhytogenX, Inc.624386772MANUFACTURE(77365-002)

Revised: 9/2023
 

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