Tan-Luxe Super Glow Broad Spectrum Sunscreen SPF 30 by Paris Presents Incorporated / Bentley Laboratories, LLC

Tan-Luxe Super Glow Broad Spectrum Sunscreen SPF 30 by

Drug Labeling and Warnings

Tan-Luxe Super Glow Broad Spectrum Sunscreen SPF 30 by is a Otc medication manufactured, distributed, or labeled by Paris Presents Incorporated, Bentley Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TAN-LUXE SUPER GLOW BROAD SPECTRUM SUNSCREEN SPF 30- avobenzone, homosalate, octisalate, octocrylene liquid 
Paris Presents Incorporated

----------

Active Ingredients

Avobenzone 3.0%, Homosalate 8.0%, Octisalate 3.0%, Octocrylene 8.0%

Purpose

Sunscreen

Directions

• Apply generously and evenly 15 minutes before sun exposure
• Use a water resistant sunscreen if swimming or sweating
• Reapply at least every 2 hours
• Children under 6 months of age: ask doctor

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.

Inactive Ingredients

Water/Aqua/Eau, Dihydroxyacetone, Butyloctyl Salicylate, Argania Spinosa Kernel Oil, Propylene Glycol, Tocopheryl Acetate, Polyglyceryl-10 Laurate, PEG-8 Stearate, Glyceryl Stearate, Erythrulose, Phenoxyethanol, Hyaluronic Acid, Cocoa Butter, Persea Gratissima (Avocado) Oil, Glycerin, Cocos Nucifera (Coconut) Oil, Aloe Barbadensis Leaf Juice, Rubus Idaeus (Raspberry) Extract, Withania Somnifera Root Extract, Cetearyl Alcohol, 1,2-Hexanediol, Fructose, Sorbitan Oleate, Xanthan Gum, Bisabolol, Fragrance/Parfum, Ethylhexylglycerin, Citric Acid, Biosaccharide Gum-4, Red 33 (CI 17200)

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.

Keep out of reach of children

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

TAN-LUXE SUPER GLOW BROAD SPECTRUM SUNSCREEN SPF 30 
avobenzone, homosalate, octisalate, octocrylene liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84782-703
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	8 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	8 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PEG-8 STEARATE (UNII: 2P9L47VI5E)
HYALURONIC ACID (UNII: S270N0TRQY)
FRUCTOSE (UNII: 6YSS42VSEV)
L-ERYTHRULOSE (UNII: WKK1W5B83O)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIHYDROXYACETONE (UNII: O10DDW6JOO)
AVOCADO OIL (UNII: 6VNO72PFC1)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)
XANTHAN GUM (UNII: TTV12P4NEE)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
ARGAN OIL (UNII: 4V59G5UW9X)
POLYGLYCERYL-10 LAURATE (UNII: MPJ2Q8WI8G)
COCONUT OIL (UNII: Q9L0O73W7L)
RASPBERRY (UNII: 4N14V5R27W)
WITHANIA SOMNIFERA ROOT (UNII: V038D626IF)
LEVOMENOL (UNII: 24WE03BX2T)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
COCOA BUTTER (UNII: 512OYT1CRR)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84782-703-02	30 mL in 1 CARTON; Type 0: Not a Combination Product	10/08/2024
2	NDC: 84782-703-01	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	10/08/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/08/2024

Labeler - Paris Presents Incorporated (005439773)

Establishment
Name	Address	ID/FEI	Business Operations
Bentley Laboratories, LLC		068351753	manufacture(84782-703)

Establishment
Name	Address	ID/FEI	Business Operations
Paris Presents Incorporated		005439773	label(84782-703)

Revised: 10/2024

Document Id: 23fc00e9-d31b-ee13-e063-6394a90a6baf

34390-5

Set id: 23fc00e9-d31a-ee13-e063-6394a90a6baf

Version: 1

Effective Time: 20241008