FDA.reportPublic FDA data

REDNESS solutions MAKEUP BROAD SPECTRUM SPF 15 WITH PROBIOTIC TECHNOLOGY

Manufacturer
CLINIQUE LABORATORIES LLC | Estee Lauder Companies Inc. | Estee Lauder N.V.
Effective date
2023-10-13
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:56:46

Label at a glance#

ProductREDNESS solutions MAKEUP BROAD SPECTRUM SPF 15 WITH PROBIOTIC TECHNOLOGY
Active ingredientOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE
Label structure9 sections

Dosage and administration

For sunscreen use: apply liberally 15 minutes before sun exposure reapply at least every two hours use a water resistant sunscreen if 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 measures including: limit time in...

Storage and handling

protect the product in this container from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 5.9%
Titanium Dioxide 3.7%
Zinc Oxide 2.9%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Use

INDICATIONS & USAGE SECTION

helps prevent sunburn

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

For sunscreen use:

  • apply liberally 15 minutes before sun exposure
  • reapply at least every two hours
  • use a water resistant sunscreen if 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 measures including:
    • limit time in the sun, especially from 10 a.m. – 2 p.m.
    • wear long-sleeved shirts, pants, hats and sunglasses
  • children under 6 months of age: ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

water\aqua\eau • methyl trimethicone • phenyl trimethicone • dimethicone • triethylhexanoin • butylene glycol • trimethylsiloxysilicate • peg-10 dimethicone • lauryl peg-9 polydimethylsiloxyethyl dimethicone • aluminum hydroxide • c12-15 alkyl benzoate • lactobacillus ferment • citrus grandis (grapefruit) peel extract • magnolia grandiflora bark extract • poria cocos sclerotium extract • astrocaryum murumuru seed butter • glycerin • caffeine • sodium myristoyl sarcosinate • caprylyl methicone • methicone • polyglyceryl-6 polyricinoleate • disteardimonium hectorite • acetyl glucosamine • isopropyl titanium triisostearate • dimethicone crosspolymer-3 • lecithin • tocopheryl acetate • laureth-7 • dimethicone/peg-10/15 crosspolymer • sodium chloride • dipropylene glycol • disodium edta • polyaminopropyl biguanide • phenoxyethanol • [+/- mica • titanium dioxide (ci 77891) • iron oxides (ci 77491, ci 77492, ci 77499)] [iln37592]

Other information

STORAGE AND HANDLING SECTION

protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CLINIQUE

redness
solutions

makeup
broad spectrum
SPF 15
with probiotic technology

1 FL.OZ.LIQ./30 ml e

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton
PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49527-070-012022-08-04C16284748780-1e4f33bdf-a87e-d8a0-e053-dadaa90a6e4eREDNESS SOLUTIONS MAKEUP BROAD SPECTRUM SPF 15 WITH PROBIOTIC TECHNOLOGY
49527-070-012022-07-29C16284748780-1e4f33bdf-a87e-d8a0-e053-dadaa90a6e4eREDNESS SOLUTIONS MAKEUP BROAD SPECTRUM SPF 15 WITH PROBIOTIC TECHNOLOGY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49527-070-01REDNESS solutions MAKEUP BROAD SPECTRUM SPF 15 WITH PROBIOTIC TECHNOLOGY30 mL in 1 BOTTLELOTION306
49527-070-01REDNESS solutions MAKEUP BROAD SPECTRUM SPF 15 WITH PROBIOTIC TECHNOLOGY1 in 1 CARTONLOTION16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49527-070REDNESS SOLUTIONS MAKEUP BROAD SPECTRUM SPF 15 WITH PROBIOTIC TECHNOLOGY (OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDE) LOTION [CLINIQUE LABORATORIES LLC]6Current NDC, Legacy NDC, 2 package rows20231014_e557e7f3-1fa7-4dde-977f-fe3f942496c0.zip

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49527-07049527-070-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYL TRIMETHICONES73ZQI0GXMIACT
WATER059QF0KO0RIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
DIMETHICONE92RU3N3Y1OIACT
TRIETHYLHEXANOIN7K3W1BIU6KIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE25G622K2RAIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
LIMOSILACTOBACILLUS REUTERI9913I24QEEIACT
GRAPEFRUITO82C39RR8CIACT
ASTROCARYUM MURUMURU SEED BUTTER12V64UPU6RIACT
GLYCERINPDC6A3C0OXIACT
CAFFEINE3G6A5W338EIACT
SODIUM MYRISTOYL SARCOSINATEJ07237209DIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
METHICONE (20 CST)6777U11MKTIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
N-ACETYLGLUCOSAMINEV956696549IACT
ISOPROPYL TITANIUM TRIISOSTEARATE949E3KBJ1IIACT
LAURETH-7Z95S6G8201IACT
SODIUM CHLORIDE451W47IQ8XIACT
DIPROPYLENE GLYCOLE107L85C40IACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
PHENOXYETHANOLHIE492ZZ3TIACT
MICAV8A1AW0880IACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
OCTINOXATE4Y5P7MUD51ACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB

Source Document#

Source XML · Source PDF

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
REDNESS solutions MAKEUP BROAD SPECTRUM SPF 15 WITH PROBIOTIC TECHNOLOGYOCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDECLINIQUE LABORATORIES LLCe557e7f3-1fa7-4dde-977f-fe3f942496c02023-10-13WarningsExact identifier
ndc (package): 49527-070-01
ndc (product): 49527-070
ndc11 (package): 49527007001
spl id: 079bb65e-7a6e-6c0a-e063-6294a90ab33a
spl set id: e557e7f3-1fa7-4dde-977f-fe3f942496c0

Reported adverse events (FAERS/openFDA)#

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