PHYSIK PERFORMANCE PLUS BROAD SPECTRUM SPF 42- homosalate,octinoxate, zinc oxide lotion

Physik by

Drug Labeling and Warnings

Physik by is a Otc medication manufactured, distributed, or labeled by Spoke Sciences, Inc., Fragrance Manufacturing, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Homosalate 8.0%
Octinoxate 7.5%
Zinc Oxide 8.1 %

Purpose

Sunscreen

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.

WARNINGS:

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.

KEEP OUT OF REACH OF CHILDREN

Directions:

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:

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

INACTIVE INGREDIENT

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

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

INGREDIENTS AND APPEARANCE

PHYSIK  PERFORMANCE PLUS BROAD SPECTRUM SPF 42
homosalate,octinoxate, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85316-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	8.1 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	8 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BIS-PEG-12 DIMETHICONE (70 MPA.S) (UNII: 2JDK5W22H4)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
DIETHYLHEXYL SEBACATE (UNII: U9LS47Q72Q)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PROPANEDIOL (UNII: 5965N8W85T)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
PEG/PPG-20/15 DIMETHICONE (UNII: 06R6X77P9C)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL PALMITATE (UNII: 2865993309)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85316-100-01	100 mL in 1 TUBE; Type 0: Not a Combination Product	04/21/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/21/2025

Labeler - Spoke Sciences, Inc. (118672931)

Registrant - Fragrance Manufacturing, Inc. (793406000)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing, Inc.		793406000	manufacture(85316-100)