TINTED MOISTURIZER SPF 30 SPF 30- octinoxate, titanium dioxide, zinc oxide cream 
Regi U.S. Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

RegiTintedSPF30BrdSpctrmMstrzr3Actvs

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

Package Label

TINTED MOISTURIZER SPF 30  SPF 30
octinoxate, titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71692-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71692-001-3535 g in 1 TUBE; Type 0: Not a Combination Product09/08/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02009/08/2017
Labeler - Regi U.S. Inc (080161899)
Establishment
NameAddressID/FEIBusiness Operations
Regi U.S. Inc080161899manufacture(71692-001)

Revised: 1/2023
Document Id: f19b3f3c-4411-89ed-e053-2995a90a3981
Set id: 58eb2d50-6794-50f1-e053-2a91aa0aec36
Version: 2
Effective Time: 20230106
 
Regi U.S. Inc