RegiTintedSPF30BrdSpctrmMstrzr4Actvs

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]

TINTED MOISTURIZER SPF 30 BROAD SPECTRUM- avobenzone, homosalate, octisalate,octocrylene 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.

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RegiTintedSPF30BrdSpctrmMstrzr4Actvs

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 7%

Purpose

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 and evenly 15 minutes before sun exposure

■ reapply

after 40 minutes if swimming or sweating

immediately after towel drying

at least every 2 hours

■ 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 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

Water, Butyloctyl Salicylate, Potassium Cetyl Phosphate, Methylpropanediol, Sodium Potassium Aluminum Silicate, C12-15 Alkyl Benzoate, Dimethicone, Glyceryl Stearate SE, Glycerin, Polyester-5, Caprylyl Glycol, Silica, Potassium Sorbate, Sodium Dehydroacetate, Tocopheryl Acetate, Pentylene Glycol, Phenylpropanol, Galactoarabinan, Xanthan Gum, Lactic Acid, Citric Acid, Fructose, Sodium Hydroxide, Urea, Allantoin, Maltose, Sodium Chloride, Sodium Lactate, Sodium Pyrrolidone Carboxylate, Trehalose, Glucose, Sodium Acetate, Sodium Hyaluronate, Titanium Dioxide, Iron Oxides

Other information

■ protect this product from excessive heat and direct sun

Questions or Comments?

Call toll free 1-877-366-7734

Package Label

TINTED MOISTURIZER SPF 30  BROAD SPECTRUM
avobenzone, homosalate, octisalate,octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71692-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM LACTATE (UNII: TU7HW0W0QT)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
UREA (UNII: 8W8T17847W)
ALLANTOIN (UNII: 344S277G0Z)
WATER (UNII: 059QF0KO0R)
FRUCTOSE (UNII: 6YSS42VSEV)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
GLYCERIN (UNII: PDC6A3C0OX)
POLYESTER-5 (TG-38) (UNII: 2L9351NW8W)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PHENYLPROPANOL (UNII: 0F897O3O4M)
GALACTOARABINAN (UNII: SL4SX1O487)
XANTHAN GUM (UNII: TTV12P4NEE)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TREHALOSE (UNII: B8WCK70T7I)
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)
SODIUM ACETATE (UNII: 4550K0SC9B)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MALTOSE (UNII: XJ6S9RV06F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71692-002-30	30 mL in 1 TUBE; Type 0: Not a Combination Product	02/22/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	02/22/2021

Labeler - Regi U.S. Inc (080161899)

Establishment
Name	Address	ID/FEI	Business Operations
Regi U.S. Inc		080161899	manufacture(71692-002)

Revised: 1/2023

Document Id: f19b3828-02cd-b8de-e053-2a95a90a8411

34390-5

Set id: bc03f8a6-d1ac-52f4-e053-2a95a90a7b4d

Version: 2

Effective Time: 20230106