SUNPROOF™ INTENSIVE LIP BALM Broad Spectrum SPF 24 Sunscreen SWEET TANGERINE

SUNPROOF INTENSIVE LIP BALM Broad Spectrum SPF 24 Sunscreen SWEET TANGERINE by

Drug Labeling and Warnings

SUNPROOF INTENSIVE LIP BALM Broad Spectrum SPF 24 Sunscreen SWEET TANGERINE 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 SWEET TANGERINE- 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 SWEET TANGERINE

Drug Facts

Active ingredients	Purpose
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, 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

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

SUNPROOF INTENSIVE LIP BALM BROAD SPECTRUM SPF 24 SUNSCREEN SWEET TANGERINE 
avobenzone, homosalate, and octisalate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77365-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	30 mg  in 1 g
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	100 mg  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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)
ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B)
CANDELILLA WAX (UNII: WL0328HX19)
STEARYL BEHENATE (UNII: A68S9UI39D)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ARGAN OIL (UNII: 4V59G5UW9X)
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)
LINALOOL, (+/-)- (UNII: D81QY6I88E)

Product Characteristics
Color	YELLOW	Score
Shape		Size
Flavor	TANGERINE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77365-003-01	1 in 1 BOX	05/12/2021	04/19/2023
1		8 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	05/12/2021	04/19/2023

Labeler - Thrive Causemetics (039299574)

Establishment
Name	Address	ID/FEI	Business Operations
PhytogenX, Inc.		624386772	MANUFACTURE(77365-003)

Revised: 9/2023

Document Id: 93cfe471-215a-4f51-b37f-92f9335ac214

34390-5

Set id: ff1681c3-6b2e-4c64-afca-a073c0015f38

Version: 2

Effective Time: 20230913