True Complexion Tinted Moisturizer SPF 15

TRUE COMPLEXION TINTED MOISTURIZER SPF 15 by

Drug Labeling and Warnings

TRUE COMPLEXION TINTED MOISTURIZER SPF 15 by is a Otc medication manufactured, distributed, or labeled by Markwins Beauty Products, Inc., Baja Fur, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TRUE COMPLEXION TINTED MOISTURIZER SPF 15- homosalate, octisalate, octocrylene, zinc oxide cream 
Markwins Beauty Products, Inc.

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True Complexion Tinted Moisturizer SPF 15

Active Ingredients

Homosalate 6.25%

Octisalate 4.50%

Octocrylene 5.00%

Zinc Oxide 4.93%

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 generously 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 the 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/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)].

Other Information

protect the product in this container from excessive heat and direct sun

Tinted Moisturizer SPF 15 Label

Tinted Moisturizer SPF 15 PDP

TRUE COMPLEXION TINTED MOISTURIZER SPF 15 
homosalate, octisalate, octocrylene, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 12027-150
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	6.25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 12027-150-01	27 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2022	03/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/01/2022	03/01/2023

Labeler - Markwins Beauty Products, Inc. (135407760)

Establishment
Name	Address	ID/FEI	Business Operations
Baja Fur, S.A. de C.V.		821533098	manufacture(12027-150) , pack(12027-150) , label(12027-150)

Revised: 12/2023

Document Id: 0d99b408-9846-20a5-e063-6294a90a9f65

34390-5

Set id: e10b15d5-f6d0-3907-e053-2995a90a066b

Version: 2

Effective Time: 20231228