PANOXYL OIL AM CONTROL MOISTURIZER- zinc oxide lotion

PanOxyl Oil AM Control Moisturizer by

Drug Labeling and Warnings

PanOxyl Oil AM Control Moisturizer by is a Otc medication manufactured, distributed, or labeled by Crown Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Zinc Oxide 17%

Purpose

Sunscreen

Use

• helps prevent sunburn

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 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

shake well prior to use

apply liberally 15 minutes before sun exposure

children under 6 months of age: Ask a doctor

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 value 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.

reapply at least every 2 hours

use a water resistant suscreen if swimming for sweating

Other Information

• protect the product in this container from excessive heat and direct sun
• may stain some fabrics

Inactive Ingredients

Bisabolol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Caffeine, Caprylyl Glycol, Ethylhexylglycerin, Glycerin, 1,2-Hexanediol, Hydroxyacetophenone, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Phenethyl Alcohol, Polyglyceryl-4 Laurate/Succinate, Polyhydroxystearic Acid, Polymethylsilsesquioxane, Polysorbate 60, Purified Water, Sodium Hyaluronate, Sodium Hydroxide, Sorbitan Isostearate, Sorbitan Monostearate, Tapioca Starch, Tetrasodium Glutamate Diacetate, Tocopheryl Acetate (Vitamin E),Triethoxycaprylylsilane, Xanthan Gum

Questions?

Call 1-800-877-8869

PanOxyl Oil Control Moisturizer 1.7oz Tube

DERMATOLOGIST RECOMMENDED

PanOxyl AM

OIL CONTROL MOISTURIZER

Broad Spectrum SPF 30

Mineral Sunscreen

Lightweight Daily Moisturizer

Absorbs Excess Oil

UVA/UVB Protection

Won't Clog Pores

Net wt. 1.7oz (48g)

P12073.01

PanOxyl Oil Control Moisturizer 1.7oz Carton

PanOxyl

Oil Control Moisturizer

with Mineral Sunscreen

to Help Manage Blemishes

17% ZINC OXIDE

BROAD SPECTRUM SPF 30

Lightweight daily moisturizer

Absorbs excess oil

UVA/UVB Protection

DERMATOLOGIST RECOMMENDED

Net wt. 1.7 oz (48 g)

P12074.01

INGREDIENTS AND APPEARANCE

PANOXYL OIL AM CONTROL MOISTURIZER 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0316-0269
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	170 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
LEVOMENOL (UNII: 24WE03BX2T)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CAFFEINE (UNII: 3G6A5W338E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
POLYGLYCERYL-4 LAURATE/SUCCINATE (UNII: KAB6DS9SBS)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
STARCH, TAPIOCA (UNII: 24SC3U704I)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
POLYSORBATE 60 (UNII: CAL22UVI4M)
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0316-0269-17	1 in 1 CARTON	01/13/2023
1		48 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/13/2023

Labeler - Crown Laboratories (079035945)

Establishment
Name	Address	ID/FEI	Business Operations
Crown Laboratories		079035945	manufacture(0316-0269)