LIVE TINTED GLOW-UP HYPERPIGMENTATION ESSENTIALS- zinc oxide kit

LIVE TINTED Glow-up Hyperpigmentation Essentials by

Drug Labeling and Warnings

LIVE TINTED Glow-up Hyperpigmentation Essentials by is a Otc medication manufactured, distributed, or labeled by Live Tinted, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Zinc Oxide 18.23%

Purpose

Sunscreen

Uses

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

Warnings

For external use only

Do not use

on damaged or broken skin. Keep out of eyes. Rinse with water to remove.

Stop use

if rash occurs and ask a doctor.

Keep out of reach of children

if swallowed, get medical help orcontact a Poison Control Center right away.

Directions

Apply liberally to face and neck for everyday moisture and protection. Can be worn alone or under makeup. Reapply at least every two hours. Pair with a waterresistant SPF when swimming or sweating.

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 methods such as: Limit time in the sun, especially from 10 a.m. – 2 p.m. Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months, ask a doctor.

Inactive Ingredient

Water (Aqua), Caprylic Capric Triglyceride, C13-15 Alkane, Propanediol, C15-19 Alkane, Bisdiglyceryl Polyacyladipate-2, Tocopherol, Octyldodecanol, Polyhydroxystearic Acid, Inositol, Hippophae Rhamnoides Oil, Silica, Polyacrylate Cross-Polymer-6, Isostearic Acid, Lecithin, Polyglyceryl- 3 Polyricinoleate, Xanthan Gum, Cocoglucoside, Polyglycerin-3, Polyglyceryl-3 Lactate / Laurate, Bisabolol, Caprylhydroxamic Acid, Sodium Dilauramidoglutamide Lysine, Sodium Citrate, Citric Acid, Arachidyl Glucoside, Sodium Phytate, Glycerin, Physalis Alkekengi Calyx Extract, Biosaccharide Gum-1, Sodium Levulinate, Glyceryl Caprylate, Cetearyl Alcohol, T-butyl Alcohol, Sodium Anisate, Glucose, Betacarotene, Behenyl Alcohol, Arachidyl Alcohol, Iron Oxides (CI 77492, CI 77491)

Package Labeling:

INGREDIENTS AND APPEARANCE

LIVE TINTED GLOW-UP HYPERPIGMENTATION ESSENTIALS 
zinc oxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82153-280

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82153-280-00	1 in 1 KIT	06/06/2023

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	15 mL

Part 1 of 1

MINI HUEGUARD 3-IN-1 MINERAL SPF 30 
zinc oxide cream

Product Information
Item Code (Source)	NDC: 82153-281
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	182.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
C13-15 ALKANE (UNII: 114P5I43UJ)
PROPANEDIOL (UNII: 5965N8W85T)
C15-19 ALKANE (UNII: CI87N1IM01)
TOCOPHEROL (UNII: R0ZB2556P8)
OCTYLDODECANOL (UNII: 461N1O614Y)
INOSITOL (UNII: 4L6452S749)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
ISOSTEARIC ACID (UNII: X33R8U0062)
XANTHAN GUM (UNII: TTV12P4NEE)
COCO GLUCOSIDE (UNII: ICS790225B)
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)
LEVOMENOL (UNII: 24WE03BX2T)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
PHYTATE SODIUM (UNII: 88496G1ERL)
GLYCERIN (UNII: PDC6A3C0OX)
ALKEKENGI OFFICINARUM CALYX (UNII: AL7F9NO9HR)
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
SODIUM LEVULINATE (UNII: VK44E1MQU8)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
SODIUM ANISATE (UNII: F9WFJ28MV9)
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)
BETA CAROTENE (UNII: 01YAE03M7J)
DOCOSANOL (UNII: 9G1OE216XY)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82153-281-00	1 in 1 CARTON
1		15 mL 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 Drug	M020	06/06/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/06/2023

Labeler - Live Tinted, Inc. (118213769)