ZO SKIN HEALTH SHEER FLUID TINT BROAD-SPECTRUM SUNSCREEN SPF 45 MEDIUM-TAN- zinc oxide liquid

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

Zinc Oxide 16.0%

PURPOSE

Sunscreen

INDICATIONS & USAGE

Uses
■ helps prevent sunburn
■ higher SPF gives more sunburn protection
■ provides high protection against 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

■ keep out of eyes. Rinse with water to remove.

STOP USE

Stop use and ask a doctor if
■ rash occurs.

ASK DOCTOR

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.

OTHER SAFETY INFORMATION

Other Information
■ Protect this product from
excessive heat and direct sun.

DOSAGE & ADMINISTRATION

Directions
■ Apply liberally 15 minutes before sun exposure
■ Use a water-resistant sunscreen if
swimming or sweating
■ Reapply:
■ at least every 2 hours
■ 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.

INACTIVE INGREDIENT

Dimethicone, C12-15 Alkyl Benzoate, Dicaprylyl Carbonate, Water, Silica, Cetyl PEG/PPG-10/ 1 Dimethicone, Butylene Glycol, Glycerin, Cellulose Acetate, Dimethicone Crosspolymer, Argania Spinosa Kernel Oil, Tocopheryl Acetate, Polysorbate 20, Acrylates/ Ammonium Methacrylate Copolymer, Bisabolol, Propylene Glycol Stearate, Phenoxyethanol, Ethyl Ferulate, Triethoxycaprylylsilane,
Microcrystalline Cellulose, Sodium Chloride, Magnesium Stearate, Caprylyl Glycol, Chlorphenesin, Sea Water (Maris Aqua/Eau de mer), Sodium Citrate, Helianthus Annuus (Sunflower) Seed Oil, Medicago Sativa (Alfalfa) Extract, Ascorbic Acid, Melanin, Pentylene Glycol, Phormidium Persicinum Extract, 1,2-Hexanediol, Lecithin, Plankton Extract, Tocopherol, Beta-Glucan, Rosmarinus Officinalis (Rosemary) Leaf Extract, Ethylhexylglycerin, Retinyl Palmitate, Farnesol, Benzyl Benzoate, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499

SPL UNCLASSIFIED SECTION

Dist. by ZO Skin Health, Inc. Irvine,
CA 92618 | Made in USA with US
& imported materials
zoskinhealth.com | 927100

PRINCIPAL DISPLAY PANEL

ZO SKIN HEALTH

BY ZEIN OBAGI MD

NDC: 42851-209-50

SHEER FLUID TINT BROAD-SPECTRUM SUNSCREEN SPF 45

ZOX 12

50 mL/ 1.7 Fl. Oz.

Medium-Tan

SUN PROTECTION

INGREDIENTS AND APPEARANCE

ZO SKIN HEALTH SHEER FLUID TINT BROAD-SPECTRUM SUNSCREEN SPF 45 MEDIUM-TAN 
zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42851-209
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	160 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
POLYSORBATE 20 (UNII: 7T1F30V5YH)
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL (UNII: 3W1JG795YI)
ROSEMARY (UNII: IJ67X351P9)
PROPYLENE GLYCOL STEARATE (UNII: MZM1I680W0)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
RETINYL PALMITATE (UNII: 1D1K0N0VVC)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SOYBEAN LECITHIN (UNII: 1DI56QDM62)
CELLULOSE ACETATE (UNII: 3J2P07GVB6)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PHORMIDIUM PERSICINUM (UNII: ZA983U4810)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6)
ALFALFA TOP (UNII: SQI2NBY9KR)
CI 77492 (UNII: EX438O2MRT)
BENZYL BENZOATE (UNII: N863NB338G)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ARGANIA SPINOSA KERNEL OIL (UNII: 4V59G5UW9X)
BISABOLOL (UNII: 24WE03BX2T)
FARNESOL (UNII: EB41QIU6JL)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CI 77891 (UNII: 15FIX9V2JP)
CI 77499 (UNII: XM0M87F357)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
CI 77491 (UNII: 1K09F3G675)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
SILICA (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TOCOPHEROL (UNII: R0ZB2556P8)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
ETHYL FERULATE (UNII: 5B8915UELW)
MAGNESIUM STEARATE (UNII: 70097M6I30)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
DIMETHICONE, UNSPECIFIED (UNII: 92RU3N3Y1O)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
WATER (UNII: 059QF0KO0R)
CHLORPHENESIN (UNII: I670DAL4SZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42851-209-50	1 in 1 CARTON	04/15/2026
1		50 mL in 1 BOTTLE; 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	04/15/2026

Labeler - ZO Skin Health, Inc. (826468527)