TAN-LUXE SUPER GLOSS SPF 30 ILLUMINATING BRONZING DROPS- avobenzone, homosalate, octisalate, octocylene liquid

Tan-Luxe Super Gloss SPF 30 Illuminating Bronzing Drops by

Drug Labeling and Warnings

Tan-Luxe Super Gloss SPF 30 Illuminating Bronzing Drops by is a Otc medication manufactured, distributed, or labeled by Paris Presents Incorporated, Englewood LAB. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Directions

Shake well
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 a 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

C13-15 Alkane, Isododecane, Cetyl Ethylhexanoate, Isosorbide Dicaprylate, Ethyl Macadamiate, Dextrin Palmitate, Polyester-7, Mica, Argania Spinosa Kernel Oil, Tocopheryl Acetate, Polymethylsilsesquioxane, Neopentyl Glycol Diheptanoate, Squalane, Caprylic/Capric Triglyceride, Dextrin Palmitate/Hexyldecanoate, Methyl Methacrylate Crosspolymer, Hyaluronic Acid, Tocopherol, Phenoxyethanol, Bisabolol, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Polyglyceryl-10 Laurate, Glycerin, Water (Aqua), Polyglyceryl-10 Myristate, Isochrysis Galbana Extract, Iron Oxides (CI 77491), Iron Oxides (CI 77499), Titanium Dioxide (CI 77891).

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.

Purpose

Sunscreen

Active Ingredients

Avobenzone 3.0%, Homosalate 3.6%, Octisalate 5.0%, Octocrylene 8.0%

Image Reference

See Figure 1 (Image identifier: Product Image ) for a visual representation of the product.

INGREDIENTS AND APPEARANCE

TAN-LUXE SUPER GLOSS SPF 30 ILLUMINATING BRONZING DROPS 
avobenzone, homosalate, octisalate, octocylene liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84782-271
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	36 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	80 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
TOCOPHEROL (UNII: R0ZB2556P8)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
ISOCHRYSIS GALBANA WHOLE (UNII: H22FH39EGN)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
HYALURONIC ACID (UNII: S270N0TRQY)
LEVOMENOL (UNII: 24WE03BX2T)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
ISODODECANE (UNII: A8289P68Y2)
MICA (UNII: V8A1AW0880)
ISOSORBIDE DICAPRYLATE (UNII: 0IK29C4889)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
ARGAN OIL (UNII: 4V59G5UW9X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYESTER-7 (UNII: 0841698D2F)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
SQUALANE (UNII: GW89575KF9)
ETHYL MACADAMIATE (UNII: ANA2NCS6V1)
C13-15 ALKANE (UNII: 114P5I43UJ)
BERGAMOT OIL (UNII: 39W1PKE3JI)
POLYGLYCERYL-10 LAURATE (UNII: MPJ2Q8WI8G)
GLYCERIN (UNII: PDC6A3C0OX)
POLYGLYCERYL-10 MYRISTATE (UNII: Y9WL8QN3ZB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84782-271-01	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	10/02/2024
2	NDC: 84782-271-02	30 mL in 1 CARTON; Type 0: Not a Combination Product	10/02/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/02/2024

Labeler - Paris Presents Incorporated (005439773)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood LAB		172198223	manufacture(84782-271)

Establishment
Name	Address	ID/FEI	Business Operations
Paris Presents Incorporated		005439773	label(84782-271)