FDA.reportPublic FDA data

REVLON PHOTOREADY INSTA-FIX MAKEUP

Manufacturer
Revlon Consumer Products Corp | REVLON, INC.
Effective date
2024-12-31
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:49:54

Label at a glance#

ProductREVLON PHOTOREADY INSTA-FIX MAKEUP
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure8 sections

Indications and 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

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 4.3%

Zinc Oxide 2.8

Purpose:

Sunscreen

Uses:

INDICATIONS & USAGE SECTION

  • 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

Warnings:

WARNINGS SECTION

  • For external use only 
  • Do notuse 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 a rash occurs
  • Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control center right away

Directions:

  • Apply liberally 15 minutes before sun exposure
  • Use a water resistant sunscreen if swimming or sweating
  • Reapply at least every 2 hours
  • Children under 6 months: Ask a doctor.

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 am - 2 pm
  • Wear long-sleeved shirts, pants, hats and sunglasses.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Boron Nitride, Phenyl Trimethicone, Ozokerite, Bis-(C12-14 Alkyl PPG-2) Hexamethylenediurea, Sodium Ascorbyl Phosphate, Niacinamide, Hydrolyzed Oat Flour, Tocopheryl Acetate, Lecithin, Phytosteryl Canola Glycerides, Palmitic Acid, Oleic Acid, Ceramide 3, Tocopherol, Phytosphingosine, Hydrogenated Jojoba Oil, Ceramide 6 II, Cholesterol, Ceramide 1, Alumina, Nylon-12, Triethoxycaprylylsilane, Methicone, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Polyglyceryl-4 Isostearate, Dimethicone Crosspolymer, C12-15 Alkyl Benzoate, Sodium Lauroyl Lactylate, Linoleic Acid, Methoxy Amodimethicone/Silsesquioxane Copolymer, Stearic Acid, Triolein, Xanthan Gum, Carbomer, Sorbic Acid

May Contain Mica, Titanium Dioxide (Ci 77891), Iron Oxides (CI 77491, 77492, 77499)

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

OTC - PURPOSE SECTION

Sunscreen

Principal Display Panel:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

REVLON PHOTOREADY INSTA-FIX MAKEUP

LabelLabel

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
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10967-631-24REVLON PHOTOREADY INSTA-FIX MAKEUP10.35 mL in 1 TUBESTICK10.353

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10967-631REVLON PHOTOREADY INSTA-FIX MAKEUP (TITANIUM DIOXIDE, ZINC OXIDE) STICK [REVLON CONSUMER PRODUCTS CORP]3Current NDC, Legacy NDC, 1 package rows20250101_442f2a06-47c0-2522-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 2 · 41 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10967-63110967-631-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 38 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OIACT
ISOHEXADECANE918X1OUF1EIACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
TRIETHYLHEXANOIN7K3W1BIU6KIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)74G4R6TH13IACT
BORON NITRIDE2U4T60A6YDIACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
NIACINAMIDE25X51I8RD4IACT
OATMEAL8PI54V663YIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
LECITHIN, SOYBEAN1DI56QDM62IACT
PALMITIC ACID2V16EO95H1IACT
OLEIC ACID2UMI9U37CPIACT
TOCOPHEROLR0ZB2556P8IACT
CERAMIDE 34370DF050BIACT
PHYTOSPHINGOSINEGIN46U9Q2QIACT
HYDROGENATED JOJOBA OIL7F674YQ5SOIACT
CERAMIDE 6 IIF1X8L2B00JIACT
CHOLESTEROL97C5T2UQ7JIACT
CERAMIDE 15THT33P7X7IACT
ALUMINUM OXIDELMI26O6933IACT
NYLON-12446U8J075BIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
METHICONE (20 CST)6777U11MKTIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5)V2W71V8T0XIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
SODIUM LAUROYL LACTYLATE7243K85WFOIACT
LINOLEIC ACID9KJL21T0QJIACT
STEARIC ACID4ELV7Z65APIACT
GLYCERYL TRIOLEATEO05EC62663IACT
XANTHAN GUMTTV12P4NEEIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
SORBIC ACIDX045WJ989BIACT
ZINC OXIDESOI2LOH54ZACTIM
TITANIUM DIOXIDE15FIX9V2JPACTIB

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
REVLON PHOTOREADY INSTA-FIX MAKEUPTITANIUM DIOXIDE, ZINC OXIDERevlon Consumer Products Corp442f2a06-47c0-2522-e054-00144ff88e882024-12-31WarningsExact identifier
ndc (package): 10967-631-24
ndc (product): 10967-631
ndc11 (package): 10967063124
spl id: 2a96c4ec-8df1-1741-e063-6394a90aedb5
spl set id: 442f2a06-47c0-2522-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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