FDA.reportPublic FDA data

Face Reality Brilliant Defense Sunscreen SPF 50

Manufacturer
Face Reality, LLC
Effective date
2025-07-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:16:07

Label at a glance#

ProductFace Reality Brilliant Defense Sunscreen SPF 50
Active ingredientOCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE
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.

Dosage and administration

apply liberally 15 minutes before sun exposure reapply at least every 2 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 of 15 or higher and other sun protection measures including: limit time in the sun, especially from 1...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Octocrylene 9% Homosalate 6%
Octisalate 5% Avobenzone 3%

Purpose

OTC - PURPOSE SECTION

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 not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

  • if rash occurs.

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 15 minutes before sun exposure
  • reapply at least every 2 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 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: Ask a doctor

Other information

SPL UNCLASSIFIED SECTION

  • Protect the product from excessive heat and direct sun.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Water (Aqua), Carthamus Tinctorius (Safflower) Oleosomes, Glycerin, Butyloctyl Salicylate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Allantoin, Arctostaphylos Uva-Ursi Leaf Extract, Sodium Hyaluronate, Panthenol, Tocopheryl Acetate, Bisabolol, Caprylic/Capric Triglyceride, Coco-Caprylate/Caprate, Morus Nigra Leaf Extract, Myrica Cerifera (Bayberry) Bark Extract, Bis-Dodecylhexadecyl Dimer Dilinoleate/Propanediol Copolymer, Silica, Phenoxyethanol, Lauryl Glucoside, Polyglyceryl-6 Laurate, Aminopropyl Ascorbyl Phosphate, C12-15 Alkyl Benzoate, Calcium Sodium Borosilicate, Ethylhexylglycerin, Diethylhexyl Syringylidenemalonate, Xanthan Gum, Myristyl Glucoside, Raspberry Ketone, Sodium Stearoyl Glutamate, Polyhydroxystearic Acid, Dimethicone, Polyglyceryl-6 Polyricinoleate, Tetrasodium Glutamate Diacetate, Dilinoleic Acid/Butanediol Copolymer, Castor Oil/IPDI Copolymer, Sodium Hydroxide, Propanediol, Butylene Glycol, Iron Oxide (CI 77491)

Questions or comments?

OTC - QUESTIONS SECTION

1-866-477-3077

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70707-455-01Face Reality Brilliant Defense Sunscreen SPF 5060 mL in 1 TUBECREAM601

Products#

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

DailyMed product names page 1 of 2 · 48 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70707-45570707-455-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 45 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)86FQE96TZ4IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
BIS-DODECYLHEXADECYL DIMER DILINOLEATE/PROPANEDIOL COPOLYMERCH47CU874TIACT
C15-19 ALKANECI87N1IM01IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
WATER059QF0KO0RIACT
CARTHAMUS TINCTORIUS SEED OLEOSOMES9S60Q72309IACT
GLYCERINPDC6A3C0OXIACT
ALLANTOIN344S277G0ZIACT
ARCTOSTAPHYLOS UVA-URSI LEAF3M5V3D1X36IACT
SODIUM HYALURONATEYSE9PPT4THIACT
PANTHENOLWV9CM0O67ZIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
BISABOLOL24WE03BX2TIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
COCOYL CAPRYLOCAPRATE8D9H4QU99HIACT
MORUS NIGRA LEAF9354SX710IIACT
MYRICA CERIFERA ROOT BARKS46HJ3710DIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
PHENOXYETHANOLHIE492ZZ3TIACT
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT
LAURYL GLUCOSIDE76LN7P7UCUIACT
POLYGLYCERYL-6 LAURATEQ48X4BL3TVIACT
AMINOPROPYL ASCORBYL PHOSPHATE290O2PQ83RIACT
CALCIUM SODIUM BOROSILICATE4MM76N4WMYIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
DIETHYLHEXYL SYRINGYLIDENEMALONATE3V5U97P248IACT
XANTHAN GUMTTV12P4NEEIACT
MYRISTYL GLUCOSIDE6AK28695LFIACT
RASPBERRY KETONE7QY1MH15BGIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
DIMETHICONE92RU3N3Y1OIACT
POLYGLYCERYL-6 POLYRICINOLEATEYPM0ZOC2HRIACT
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
DILINOLEIC ACID/BUTANEDIOL COPOLYMER1F2S8T535OIACT
CASTOR OIL/IPDI COPOLYMERGSA2TXZ34GIACT
SODIUM HYDROXIDE55X04QC32IIACT
PROPANEDIOL5965N8W85TIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
FERRIC OXIDE RED1K09F3G675IACT

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
Face Reality Brilliant Defense Sunscreen SPF 50OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEFace Reality,LLC618f58b7-2f29-4dff-8c3a-4fdbe1eb8ce42025-07-29WarningsExact identifier
ndc (package): 70707-455-01
ndc (product): 70707-455
ndc11 (package): 70707045501
spl id: 3b16f4e6-63a7-9249-e063-6394a90a4461
spl set id: 618f58b7-2f29-4dff-8c3a-4fdbe1eb8ce4

Reported adverse events (FAERS/openFDA)#

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