LIVE TINTED HUEGUARD 3-IN-1 MINERAL SUNSCREEN MOISTURIZER PRIMER BROAD SPECTRUM SPF 30- zinc oxide cream

LIVE TINTED Hueguard 3-in-1 Mineral Sunscreen Moisturizer Primer Broad Spectrum SPF 30 by

Drug Labeling and Warnings

LIVE TINTED Hueguard 3-in-1 Mineral Sunscreen Moisturizer Primer Broad Spectrum SPF 30 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.  Rinse with water to remove. Keep out of eyes. 

Stop use if rash occurs

and ask a doctor.

Keep out of reach of children

if swallowed, get medical help or contact 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 water-resistant SPF when swimming or sweating. 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 am – 2 pm. Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months, ask a doctor.







Sun Protection Measures

Inactive Ingredients

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  ROSSPOLYMER- 6, ISOSTEARIC ACID, LECITHIN, POLYGLYCERYL-3 POLYRICINOLEATE, XANTHAN GUM, COCO-GLUCOSIDE, POLYGLYCERIN-3, OLYGLYCERYL- 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), IRON OXIDE (CI 77491)

Package Labeling: 150mL

Package Labeling: 15mL

INGREDIENTS AND APPEARANCE

LIVE TINTED HUEGUARD 3-IN-1 MINERAL SUNSCREEN MOISTURIZER PRIMER BROAD SPECTRUM SPF 30 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82153-271
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)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
C15-19 ALKANE (UNII: CI87N1IM01)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
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 (UNII: 1Q73Q2JULR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
PHYTATE SODIUM (UNII: 88496G1ERL)
GLYCERIN (UNII: PDC6A3C0OX)
PHYSALIS ALKEKENGI 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 RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82153-271-00	1 in 1 CARTON	03/08/2023
1		150 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 82153-271-01	1 in 1 CARTON	03/08/2023
2		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	03/08/2023

Labeler - Live Tinted, Inc. (118213769)