FDA.reportPublic FDA data

Powerbright Moisturizer SPF 50

Manufacturer
Dermalogica, LLC. | McKenna
Effective date
2024-12-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:49:30

Label at a glance#

ProductPowerbright Moisturizer SPF 50
Active ingredientOctocrylene, Homosalate, Avobenzone, Octisalate
Label structure10 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 30 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 help 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, especia...

Storage and handling

Protect this product from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Octocrylene 8.0%
Homosalate 5.0%
Avobenzone 3.0%
Octisalate 3.0%

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.

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 30 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 help 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-sleeve shirts, pants, hats and sunglasses.
  • Children under 6 months: ask a doctor.

Other information

STORAGE AND HANDLING SECTION

  • Protect this product from excessive heat and direct sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water/Aqua/Eau, Carthamus Tinctorius (Safflower) Oleosomes, Butylene Glycol, C12-15 Alkyl Benzoate, Niacinamide, Polysorbate 80, Laminaria Digitata Extract, Lavandula Hybrida Oil, Lavandula Angustifolia (Lavender) Flower Extract, Cananga Odorata Flower Oil, Eucalyptol, Glycerin, Pentylene Glycol, PPG-12/SMDI Copolymer, Bisabolol, Ethylhexylglycerin, Caprylyl Glycol, Glycogen, Sodium Hyaluronate, Dipotassium Glycyrrhizate, Gluconolactone, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Glyceryl Polyacrylate, Propanediol, Trisodium Ethylenediamine Disuccinate, Ammonium Acryloyldimethyltaurate/ VP Copolymer, Polymethylsilsesquioxane, Silica, Sodium Benzoate, Sodium Hydroxide, Benzyl Benzoate, Benzyl Salicylate, Farnesol, Limonene, Linalool, Geraniol, Isoeugenol.

Questions or comments

OTC - QUESTIONS SECTION

Call toll free
1-800-831-5150 in the US.

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

powerbright
moisturizer

SPF
50

broad spectrum

dark spot defense

1.7 US FL OZ / 50 mL e

dermalogica

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton
PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68479-020-01Powerbright Moisturizer SPF 5012 mL in 1 TUBELOTION122
68479-020-02Powerbright Moisturizer SPF 5050 mL in 1 BOTTLELOTION502
68479-020-02Powerbright Moisturizer SPF 501 in 1 CARTONLOTION12
68479-020-05Powerbright Moisturizer SPF 507 mL in 1 TUBELOTION72
68479-020-06Powerbright Moisturizer SPF 502 mL in 1 POUCHLOTION22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68479-020POWERBRIGHT MOISTURIZER SPF 50 (OCTOCRYLENE, HOMOSALATE, AVOBENZONE, AND OCTISALATE) LOTION [DERMALOGICA, LLC.]2Current NDC, Legacy NDC, 5 package rows20250101_02c731ee-c5cb-4158-9b1f-e826593c3526.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
68479-02068479-020-02, 68479-020-01, 68479-020-05, 68479-020-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 39 matching rows.

Name, UNII, Kind table
NameUNIIKind
Octocrylene5A68WGF6WMACTIB
HomosalateV06SV4M95SACTIB
AvobenzoneG63QQF2NOXACTIB
Octisalate4X49Y0596WACTIB
Water059QF0KO0RIACT
SAFFLOWER OIL65UEH262ISIACT
Butylene Glycol3XUS85K0RAIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
Niacinamide25X51I8RD4IACT
Polysorbate 806OZP39ZG8HIACT
GlycerinPDC6A3C0OXIACT
Ammonium Acryloyldimethyltaurate/VP CopolymerW59H9296ZGIACT
Pentylene Glycol50C1307PZGIACT
Propanediol5965N8W85TIACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
PPG-12/Smdi Copolymer1BK9DDD24EIACT
Caprylyl Glycol00YIU5438UIACT
Glycogen309GSC92U1IACT
LAVANDIN OIL9RES347CKGIACT
YLANG-YLANG LEAF OIL6W864D0X3XIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
LEVOMENOL24WE03BX2TIACT
GluconolactoneWQ29KQ9POTIACT
Ethylhexylglycerin147D247K3PIACT
HYALURONATE SODIUMYSE9PPT4THIACT
GLYCYRRHIZINATE DIPOTASSIUMCA2Y0FE3FXIACT
Trisodium Ethylenediamine DisuccinateYA22H34H9QIACT
Sodium BenzoateOJ245FE5EUIACT
Sodium Hydroxide55X04QC32IIACT
LAMINARIA DIGITATA15E7C67EE8IACT
EucalyptolRV6J6604TKIACT
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER19AH1RAF4MIACT
LINALOOL, (+/-)-D81QY6I88EIACT
Benzyl BenzoateN863NB338GIACT
Benzyl SalicylateWAO5MNK9TUIACT
FarnesolEB41QIU6JLIACT
LIMONENE, (+)-GFD7C86Q1WIACT
GeraniolL837108USYIACT
Isoeugenol5M0MWY797UIACT

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
Powerbright Moisturizer SPF 50OCTOCRYLENE, HOMOSALATE, AVOBENZONE, AND OCTISALATEDermalogica, LLC.02c731ee-c5cb-4158-9b1f-e826593c35262024-12-27WarningsExact identifier
ndc (package): 68479-020-06
ndc (package): 68479-020-02
ndc (package): 68479-020-01
ndc (package): 68479-020-05
ndc (product): 68479-020
ndc11 (package): 68479002002
ndc11 (package): 68479002001
ndc11 (package): 68479002005
ndc11 (package): 68479002006
spl id: bf9d0db0-b478-475f-aeb0-9a8ddd643ac2
spl set id: 02c731ee-c5cb-4158-9b1f-e826593c3526

Reported adverse events (FAERS/openFDA)#

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