TINTED MOISTURIZER SPF 30 SPF 30- octinoxate, titanium dioxide, zinc oxide cream

Tinted Moisturizer SPF 30 by

Drug Labeling and Warnings

Tinted Moisturizer SPF 30 by is a Otc medication manufactured, distributed, or labeled by Regi U.S. Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Octinoxate 7.5%

Titanium Dioxide 3.5%

Zinc Oxide 3%

Purpose

Sunscreen

Sunscreen

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 product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

apply liberally 15 minutes before sun exposure reapply at least every 2 hours use a water resistant sunscreen if swimming or sweating 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 sun, especially from 10 a.m.- 2 p.m.

wear long-sleeve shirts, pants, hats, and sunglasses

children under 6 months: Ask a doctor

Inactive Ingredients

Purified Water, Cyclopentasiloxane, Isononyl Isononanoate, Phenyl Trimethicone, Alcohol Denat., Lauryl PEG-8 Dimethicone, Disteardimonium Hectorite, Sodium Chloride, PEG-10 Dimethicone, Talc, Caprylyl Glycol, Alumina, Stearic Acid, Phenoxyethanol, Potassium Sorbate, Sodium Dehydroacetate, Methicone, Hexylene Glycol, Propanediol, Tocopheryl Acetate, Hydrogen Dimethicone, Boerhavia Diffusa Root Extract, Ascorbyl Palmitate MAY CONTAIN: Iron Oxides (CI 77491, CI 77492, CI 77499), Titanium Dioxide (CI 77891)

Other information

protect this product from excessive heat and direct sun

Questions or Comments?

Call toll free 1-866-983-8582

Package Label

INGREDIENTS AND APPEARANCE

TINTED MOISTURIZER SPF 30  SPF 30
octinoxate, titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71692-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	3 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
ALCOHOL (UNII: 3K9958V90M)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
TALC (UNII: 7SEV7J4R1U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALUMINUM OXIDE (UNII: LMI26O6933)
STEARIC ACID (UNII: 4ELV7Z65AP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
METHICONE (20 CST) (UNII: 6777U11MKT)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
PROPANEDIOL (UNII: 5965N8W85T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
BOERHAVIA DIFFUSA ROOT (UNII: KR0SR09KYL)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71692-001-35	35 g in 1 TUBE; Type 0: Not a Combination Product	09/08/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	09/08/2017

Labeler - Regi U.S. Inc (080161899)

Establishment
Name	Address	ID/FEI	Business Operations
Regi U.S. Inc		080161899	manufacture(71692-001)