FDA.reportPublic FDA data

Face Reality Power Mineral 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 01:16:09

Label at a glance#

ProductFace Reality Power Mineral Sunscreen SPF 50
Active ingredientZINC OXIDE
Label structure9 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

Zinc Oxide 19%

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), Coco-Caprylate/Caprate, Dimethicone, Squalane, Glycerin, Cetearyl Alcohol, Dicaprylyl Carbonate, Isopentyldiol, Polyhydroxystearic Acid, Sorbitan Olivate, Coco-Glucoside, Pongamia Pinnata Seed Extract, Ceramide NP, Polysilicone-11, Tocopheryl Acetate, Caprylyl/Capryl Glucoside, Linoleic Acid, Polyglyceryl 10 Stearate, Phytosterols, Panthenol, Bisabolol, Allantoin, Sodium Hyaluronate, Hydrogenated Lecithin, Dipotassium Glycyrrhizate, Asiaticoside, Camellia Sinensis Leaf Extract, Madecassic Acid, Asiatic Acid, Linolenic Acid, Centella Asiatica Extract, Tocopherol, Phenoxyethanol, PEG-10 Dimethicone, Ethylhexylglycerin, Acacia Senegal Gum, Tetrasodium Glutamate Diacetate, Xanthan Gum, Sucrose Stearate, Capryloyl Glycerin/Sebacic Acid Copolymer, Bis-Dodecylhexadecyl Dimer Dilinoleate/Propanediol Copolymer, Silica, Helianthus Annuus (Sunflower) Seed Oil, Iron Oxides (CI 77492), Sodium Citrate, Iron Oxides (CI 77499), Iron Oxides (CI 77491)

Questions or comments?

OTC - QUESTIONS SECTION

1-866-477-3077

Package Labeling: 60ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

Package Labeling: 118ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3Label3

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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70707-456-01Face Reality Power Mineral Sunscreen SPF 5060 mL in 1 TUBECREAM601
70707-456-02Face Reality Power Mineral Sunscreen SPF 50118 mL in 1 BOTTLE, PUMPCREAM1181

Products#

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

DailyMed product names page 1 of 2 · 50 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70707-45670707-456-01, 70707-456-02

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 48 matching rows.

Name, UNII, Kind table
NameUNIIKind
BIS-DODECYLHEXADECYL DIMER DILINOLEATE/PROPANEDIOL COPOLYMERCH47CU874TIACT
WATER059QF0KO0RIACT
COCOYL CAPRYLOCAPRATE8D9H4QU99HIACT
DIMETHICONE92RU3N3Y1OIACT
SQUALANEGW89575KF9IACT
GLYCERINPDC6A3C0OXIACT
CETEARYL ALCOHOL2DMT128M1SIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
ISOPENTYLDIOL19NOL5474QIACT
SORBITAN OLIVATEMDL271E3GRIACT
COCO-GLUCOSIDEICS790225BIACT
PONGAMIA PINNATA SEEDC2BRV53B1VIACT
CERAMIDE NP4370DF050BIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CAPRYLYL/CAPRYL OLIGOGLUCOSIDEE00JL9G9K0IACT
LINOLEIC ACID9KJL21T0QJIACT
POLYGLYCERYL-10 STEARATE90TF85HH91IACT
PANTHENOLWV9CM0O67ZIACT
BISABOLOL24WE03BX2TIACT
ALLANTOIN344S277G0ZIACT
HYALURONATE SODIUMYSE9PPT4THIACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT
DIPOTASSIUM GLYCYRRHIZATECA2Y0FE3FXIACT
ASIATICOSIDEPKO39VY215IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
MADECASSIC ACIDM7O1N24J82IACT
ASIATIC ACID9PA5A687X5IACT
LINOLENIC ACID0RBV727H71IACT
CENTELLA ASIATICA TRITERPENOIDS4YS74Q4G4JIACT
TOCOPHEROLR0ZB2556P8IACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ACACIA SENEGAL GUM5C5403N26OIACT
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
XANTHAN GUMTTV12P4NEEIACT
SUCROSE STEARATE274KW0O50MIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SUNFLOWER OIL3W1JG795YIIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT

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 Power Mineral Sunscreen SPF 50ZINC OXIDEFace Reality,LLC8c502e11-6e97-46d6-8775-1bbafaeb18f82025-07-29WarningsExact identifier
ndc (package): 70707-456-01
ndc (package): 70707-456-02
ndc (product): 70707-456
ndc11 (package): 70707045602
ndc11 (package): 70707045601
spl id: 3b170341-8a32-9753-e063-6394a90a1a3a
spl set id: 8c502e11-6e97-46d6-8775-1bbafaeb18f8

Reported adverse events (FAERS/openFDA)#

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