True Complexion Tinted Moisturizer 1320356-359, 1320361-364; 69514-312

TRUE COMPLEXION TINTED MOISTURIZER by

Drug Labeling and Warnings

TRUE COMPLEXION TINTED MOISTURIZER by is a Otc medication manufactured, distributed, or labeled by Markwins Beauty Brands. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TRUE COMPLEXION TINTED MOISTURIZER- homosalate, octisalate, octocrylene, zinc oxide cream 
Markwins Beauty Brands

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True Complexion Tinted Moisturizer 1320356-359, 1320361-364; 69514-312

Homosalate 6.25%

Octisalate 4.50%

Octocrylene 5.00%

Zinc Oxide 4.93%

Sunscreen

-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.

For external use only

Do not use on damage 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

For external use only

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

apply liberally 15 minutes before sun exposure
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

Water/Eau, Sorbitol, Cyclopentasiloxane, Butyloctyl Salicylate, PEG-30 Dipolyhydroxystearate, Ethylhexyl Methoxycrylene, Lecithin, Lauryl PEG/PPG-18/18 Methicone, Cetyl Alcohol, Dimethicone, Trimethylsiloxysilicate, Talc, Phenoxyethanol, Magnesium Sulfate,
Polysorbate 20, Caprylyl Glycol, Disteardimonium Hectorite, Phenyl Trimethicone, Disodium EDTA, Triethoxycaprylylsilane, Ethylhexylglycerin, Adansonia Digitata Pulp Extract, Sodium Benzoate, Xanthan Gum, Sodium Hyaluronate, Potassium Sorbate, [+/- (MAY CONTAIN/PEUT CONTENIR): Titanium Dioxide (CI 77891), Mica, Iron Oxides (CI 77491, CI 77492, CI 77499)].

TRUE COMPLEXION TINTED MOISTURIZER 
homosalate, octisalate, octocrylene, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69514-312
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	6.25 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	4.93 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MICA (UNII: V8A1AW0880)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
FERRIC OXIDE RED (UNII: 1K09F3G675)
WATER (UNII: 059QF0KO0R)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ADANSONIA DIGITATA FRUIT PULP (UNII: P65OHK3GHP)
SODIUM BENZOATE (UNII: OJ245FE5EU)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
TRIMETHYLSILYL TRIHYDROGEN SILICATE (UNII: OU6EUR7UAY)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SORBITOL (UNII: 506T60A25R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
DIMETHICONE (UNII: 92RU3N3Y1O)
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)
CETYL ALCOHOL (UNII: 936JST6JCN)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
TALC (UNII: 7SEV7J4R1U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69514-312-01	27 g in 1 TUBE; Type 0: Not a Combination Product	11/11/2022	12/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	11/11/2022	12/01/2023

Labeler - Markwins Beauty Brands (078890119)

Revised: 12/2023

Document Id: 0d99ccbc-2076-337b-e063-6394a90a6903

34390-5

Set id: f411c3c7-4f8b-ebd2-e053-2995a90a05b8

Version: 2

Effective Time: 20231228