FDA.reportPublic FDA data

Physik

Manufacturer
Spoke Sciences, Inc. | Fragrance Manufacturing, Inc.
Effective date
2025-03-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:39:37

Label at a glance#

ProductPhysik Performance Plus Broad Spectrum SPF 42
Active ingredientZINC OXIDE, OCTINOXATE, HOMOSALATE
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. • Children under 6 months of age: Ask a doctor. REAPPLY: After 80 minutes of swimming or sweating. Immediately after towel drying. At least every 2 hours. 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 ...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Homosalate 8.0%
Octinoxate 7.5%
Zinc Oxide 8.1 %

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 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 rash occurs.

  • 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 15 minutes before sun exposure.
• Children under 6 months of age: Ask a doctor.

REAPPLY:

  • After 80 minutes of swimming or sweating.
  • Immediately after towel drying.
  • At least every 2 hours.


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 sleeves shirts, pants, hats, and sunglasses.

Other Information:

OTHER SAFETY INFORMATION

  • Protect the product in this container from excessive heat and direct sun.
  • May stain some fabrics.

INACTIVE INGREDIENT SECTION

ALUMINUM STARCH OCTENYLSUCCINATE,ASCORBYL PALMITATE,BIS-PEG-12 DIMETHICONE (70 MPA.S) (BEESWAX),CAPRYLHYDROXAMIC ACID,CAPRYLYL GLYCOL,CYCLOPENTASILOXANE,DECYL GLUCOSIDE,DIETHYLHEXYL SEBACATE,ETHYLHEXYL METHOXYCINNAMATE,ETHYLHEXYL PALMITATE,ETHYLHEXYLGLYCERIN,HYDROGENATED CASTOR OIL,METHYLPROPANEDIOL,PEG/PPG-20/15 DIMETHICONE,PEG-30 DIPOLYHYDROXYSTEARATE,DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER Soft (POLYSILICONE-11),PROPANEDIOL,SILICON DIOXIDE (SILICA),SODIUM CHLORIDE, .ALPHA.-TOCOPHEROL ACETATE (TOCOPHERYL ACETATE),TRIETHOXYCAPRYLYLSILANE, WATER

Description

DESCRIPTION SECTION

PERFORMANCE+
BROAD SPECTRUM SPF 42 SUNSCREEN FOR SPORT
NON-GREASY
CLEAR ZINC OXIDE
WATER RESISTANT (80 MIN)
FRAGRANCE + PARABEN FREE

42 SPF Broad Spectrum Sunscreen for Sports Water Resistant 80 minutes NET WT. 3.4fl.oz / 100mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PHYSIK 42 SPF Broad Spectrum SunscreenPHYSIK 42 SPF Broad Spectrum Sunscreen

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85316-100PHYSIK PERFORMANCE PLUS BROAD SPECTRUM SPF 42 (HOMOSALATE,OCTINOXATE, ZINC OXIDE) LOTION [SPOKE SCIENCES, INC.]1Unmatched20250421_2f9d9872-68d8-cdc2-e063-6294a90a6463.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85316-10085316-100-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
BIS-PEG-12 DIMETHICONE (70 MPA.S)2JDK5W22H4IACT
ASCORBYL PALMITATEQN83US2B0NIACT
CYCLOPENTASILOXANE0THT5PCI0RIACT
DIETHYLHEXYL SEBACATEU9LS47Q72QIACT
ZINC OXIDESOI2LOH54ZACTIB
PEG-30 DIPOLYHYDROXYSTEARATE9713Q0S7FOIACT
OCTINOXATE4Y5P7MUD51ACTIB
ETHYLHEXYLGLYCERIN147D247K3PIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
CAPRYLYL GLYCOL00YIU5438UIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PROPANEDIOL5965N8W85TIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
HOMOSALATEV06SV4M95SACTIB
PEG/PPG-20/15 DIMETHICONE06R6X77P9CIACT
METHYLPROPANEDIOLN8F53B3R4RIACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
SODIUM CHLORIDE451W47IQ8XIACT
WATER059QF0KO0RIACT
ETHYLHEXYL PALMITATE2865993309IACT

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
4df1a67f-7cd0-44fc-e063-6294a90a621a2f9d9872-68d8-cdc2-e063-6294a90a64632026-03-26WarningsExact identifier
spl set id: 2f9d9872-68d8-cdc2-e063-6294a90a6463

Reported adverse events (FAERS/openFDA)#

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