ZO SKIN HEALTH DAILY MINERAL SUNSHADE BROAD-SPECTRUM SUNSCREEN SPF 45- titanium dioxide, zinc oxide lotion

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

Active Ingredients
Titanium Dioxide 5.4%
Zinc Oxide 13.2%

PURPOSE

Propose

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 AND PRECAUTIONS

Warnings

For external use only.

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.

DOSAGE & ADMINISTRATION

Directions

■ Apply liberally 15 minutes before sun exposure and as needed.

■ 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

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun

INACTIVE INGREDIENT

Dimethicone, Water, Squalane, PEG-10 Dimethicone, Propanediol, Glycerin, Tribehenin, Dimethicone Crosspolymer, Cetyl PEG/PPG-10/1 Dimethicone, Silica, Hexyl Laurate, Polyglyceryl-4 Isostearate, Titanium Dioxide, Bisabolol, Lactobacillus Ferment, Scutellaria Baicalensis Root Extract, Cordyceps Militaris Mycelium Extract, Glycyrrhiza Uralensis (Licorice) Root Extract, Tocopheryl Acetate, Medicago Sativa (Alfalfa) Extract, Phormidium Persicinum Extract, Lecithin, Phenoxyethanol, Plankton Extract, Beta-Glucan, Stearic Acid, Microcrystalline Cellulose, Alumina, Butylene Glycol, Sea Water, Sodium Chloride, Sodium Citrate, Mica, Triethoxycaprylylsilane, Melanin, Pentylene Glycol, Ascorbic Acid, 1,2-Hexanediol, Ethylhexylglycerin, Tin Oxide, Retinyl Palmitate, Titanium Dioxide (CI 77891), Iron Oxides (CI 77492, CI 77491, CI77499).

SPL UNCLASSIFIED SECTION

Dist. by ZO Skin Health, Inc. Irvine, CA 92618 | Made in USA with US & imported materials zoskinhealth.com | 931900

PRINCIPAL DISPLAY PANEL

ZO® SKIN HEALTH

BY ZEIN OBAGI MD

NDC: 42851-201-45

DAILY MINERAL SUNSHADE BROAD-SPECTRUM SUNSCREEN SPF 45

ZOX12

FAIR

Sun Protection

45mL/ 1.5Fl.Oz.

INGREDIENTS AND APPEARANCE

ZO SKIN HEALTH DAILY MINERAL SUNSHADE BROAD-SPECTRUM SUNSCREEN SPF 45 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42851-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	132 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	54 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44)
PROPANEDIOL (UNII: 5965N8W85T)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
SCHIZOPHYLLAN (UNII: 7F763NNC9X)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
ALUMINA (UNII: LMI26O6933)
DIMETHICONE (UNII: 92RU3N3Y1O)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
MICA (UNII: V8A1AW0880)
GLYCERIN (UNII: PDC6A3C0OX)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
GLYCYRRHIZA URALENSIS ROOT (UNII: 42B5YD8F0K)
SOYBEAN LECITHIN (UNII: 1DI56QDM62)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CI 77499 (UNII: XM0M87F357)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
CI 77491 (UNII: 1K09F3G675)
PHORMIDIUM PERSICINUM (UNII: ZA983U4810)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TIN OXIDE (UNII: KM7N50LOS6)
CI 77492 (UNII: EX438O2MRT)
RETINYL PALMITATE (UNII: 1D1K0N0VVC)
ALFALFA TOP (UNII: SQI2NBY9KR)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6)
SILICA (UNII: ETJ7Z6XBU4)
BISABOLOL (UNII: 24WE03BX2T)
LIMOSILACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42851-201-45	1 in 1 CARTON	04/15/2026
1		45 mL 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	04/15/2026

Labeler - ZO Skin Health Inc. (826468527)