ZO SKIN HEALTH SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30- titanium dioxide and zinc oxide cream

ZO Skin Health Sunscreen Plus Primer Broad-Spectrum SPF 30 by

Drug Labeling and Warnings

ZO Skin Health Sunscreen Plus Primer Broad-Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by ZO Skin Health, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Titanium Dioxide 1.0%	Sunscreen
Zinc Oxide 20.0%	Sunscreen

Uses

• 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 use and ask a doctor if

• rash or irritation develops and lasts.

Keep out of reach of children.

• If swallowed, get medical help or contact a Poison Control Center right away.

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: 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 Information

• Protect this product from excessive heat and direct sun.

Inactive Ingredients

Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, PEG-10 Dimethicone, Phenyl Trimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Glycyrrhiza Uralensis (Licorice) Root Extract, Helianthus Annuus (Sunflower) Seed Oil, Centella Asiatica Leaf Extract, Ecklonia Kurome Extract, Glycine Soja (Soybean) Seed Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Hexyl Laurate, Polyglyceryl-4 Isostearate, Tribehenin, Bisabolol, Cetyl PEG/PPG-10/1 Dimethicone, Water, Glycerin, Squalane, Polymethyl Methacrylate, Dimethiconol, Caprylic/Capric Triglyceride, Stearic Acid, Alumina, Caprylyl Glycol, Behenyl Behenate, Melanin, Tocopheryl Acetate, Ethyl Ferulate, Polyglyceryl-5 Trioleate, Triethoxycaprylylsilane, Ascorbic Acid, Retinyl Palmitate, Disodium Uridine Phosphate, Ethylhexylglycerin, Tocopherol, Myristoyl Pentapeptide-8, Pentylene Glycol, Phenoxyethanol, Chlorphenesin, Iron Oxides.

SPL UNCLASSIFIED SECTION

Dist. by ZO Skin Health, Inc. Irvine, CA 92618

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

ZO® SKIN HEALTH
BY ZEIN OBAGI MD

NDC: 42851-060-30

SUNSCREEN + PRIMER
BROAD-SPECTRUM
SPF 30

ZOX12™

30 mL / 1 Fl. Oz.

INGREDIENTS AND APPEARANCE

ZO SKIN HEALTH SUNSCREEN PLUS PRIMER BROAD-SPECTRUM SPF 30 
titanium dioxide and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42851-060
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	10 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	200 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
GLYCYRRHIZA URALENSIS (UNII: 42B5YD8F0K)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CENTELLA ASIATICA LEAF (UNII: 6810070TYD)
ECKLONIA KUROME (UNII: 802YF989GT)
SOYBEAN (UNII: L7HT8F1ZOD)
ROSEMARY (UNII: IJ67X351P9)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
LEVOMENOL (UNII: 24WE03BX2T)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SQUALANE (UNII: GW89575KF9)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM OXIDE (UNII: LMI26O6933)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
BEHENYL BEHENATE (UNII: K8NU647RJ0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ETHYL FERULATE (UNII: 5B8915UELW)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
URIDINE MONOPHOSPHATE DISODIUM (UNII: KD8E20071T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
TOCOPHEROL (UNII: R0ZB2556P8)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42851-060-15	1 in 1 CARTON	10/31/2019
1		15 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2	NDC: 42851-060-30	1 in 1 CARTON	10/31/2019
2		30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
3	NDC: 42851-060-75	1 in 1 CARTON	10/31/2019
3		75 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	10/31/2019

Labeler - ZO Skin Health, Inc. (826468527)

Establishment
Name	Address	ID/FEI	Business Operations
Thibiant International, Inc.		083913913	MANUFACTURE(42851-060)