FDA.reportPublic FDA data

ZINC OXIDE

Manufacturer
Live Tinted, Inc.
Effective date
2023-10-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:58:21

Label at a glance#

ProductLIVE TINTED Hueguard 3-in-1 Mineral Sunscreen Moisturizer Primer Broad Spectrum SPF 30
Active ingredientZINC OXIDE
Label structure7 sections

Indications and 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.

Dosage and administration

• 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 me...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 18.23%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

• 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

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

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

Stop use if rash occurs

OTC - STOP USE SECTION

and ask a doctor.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

INACTIVE INGREDIENT SECTION

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 LABEL.PRINCIPAL DISPLAY PANEL

Outer Package2Outer Package2Inner Label2Inner Label2

Package Labeling: 15mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer PackageOuter PackageInner PackageInner Package

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82153-271-00LIVE TINTED Hueguard 3-in-1 Mineral Sunscreen Moisturizer Primer Broad Spectrum SPF 301 in 1 CARTONCREAM12
82153-271-00LIVE TINTED Hueguard 3-in-1 Mineral Sunscreen Moisturizer Primer Broad Spectrum SPF 30150 mL in 1 TUBECREAM1502
82153-271-01LIVE TINTED Hueguard 3-in-1 Mineral Sunscreen Moisturizer Primer Broad Spectrum SPF 301 in 1 CARTONCREAM12
82153-271-01LIVE TINTED Hueguard 3-in-1 Mineral Sunscreen Moisturizer Primer Broad Spectrum SPF 3015 mL in 1 TUBECREAM152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82153-271LIVE TINTED HUEGUARD 3-IN-1 MINERAL SUNSCREEN MOISTURIZER PRIMER BROAD SPECTRUM SPF 30 (ZINC OXIDE) CREAM [LIVE TINTED, INC.]2Current NDC, 4 package rows20231030_d177b085-2bbd-49c1-b02b-a7b8d8ee0468.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 38 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82153-27182153-271-00, 82153-271-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
C13-15 ALKANE114P5I43UJIACT
PENTYLENE GLYCOL50C1307PZGIACT
C15-19 ALKANECI87N1IM01IACT
BIS-DIGLYCERYL POLYACYLADIPATE-26L246LAM9TIACT
TOCOPHEROLR0ZB2556P8IACT
OCTYLDODECANOL461N1O614YIACT
INOSITOL4L6452S749IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S)Q7UI015FF9IACT
ISOSTEARIC ACIDX33R8U0062IACT
XANTHAN GUMTTV12P4NEEIACT
COCO GLUCOSIDEICS790225BIACT
POLYGLYCERIN-34A0NCJ6RD6IACT
LEVOMENOL24WE03BX2TIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
SODIUM DILAURAMIDOGLUTAMIDE LYSINEMNJ7VPT2R5IACT
SODIUM CITRATE1Q73Q2JULRIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ARACHIDYL GLUCOSIDE6JVW35JOOJIACT
PHYTATE SODIUM88496G1ERLIACT
GLYCERINPDC6A3C0OXIACT
PHYSALIS ALKEKENGI CALYXAL7F9NO9HRIACT
BIOSACCHARIDE GUM-1BB4PU4V09HIACT
SODIUM LEVULINATEVK44E1MQU8IACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
TERT-BUTYL ALCOHOLMD83SFE959IACT
SODIUM ANISATEF9WFJ28MV9IACT
ANHYDROUS DEXTROSE5SL0G7R0OKIACT
BETA CAROTENE01YAE03M7JIACT
DOCOSANOL9G1OE216XYIACT
ARACHIDYL ALCOHOL1QR1QRA9BUIACT
FERRIC OXIDE RED1K09F3G675IACT
ZINC OXIDESOI2LOH54ZACTIM

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LIVE TINTED Hueguard 3-in-1 Mineral Sunscreen Moisturizer Primer Broad Spectrum SPF 30ZINC OXIDELive Tinted, Inc.d177b085-2bbd-49c1-b02b-a7b8d8ee04682023-10-28WarningsExact identifier
ndc (package): 82153-271-00
ndc (package): 82153-271-01
ndc (product): 82153-271
ndc11 (package): 82153027101
ndc11 (package): 82153027100
spl id: 08c16579-fb9a-5c01-e063-6294a90af226
spl set id: d177b085-2bbd-49c1-b02b-a7b8d8ee0468

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.