The Healthy Foundation 10029-10040, 10603-10606, 11100-11103, 69514-303

The Healthy Foundation by

Drug Labeling and Warnings

The Healthy Foundation by is a Otc medication manufactured, distributed, or labeled by Markwins Beauty Brands. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

THE HEALTHY FOUNDATION SPF 20- octinoxate cream 
Markwins Beauty Brands

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The Healthy Foundation 10029-10040, 10603-10606, 11100-11103, 69514-303

Octinoxate 3%

Sunscreen

helps prevent sunburn

if used as sdirected with other sun protection measures (see Directions), decreases the risk of skin cancer and early 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

If 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, Cyclopentasiloxane, PEG-10 Dimethicone, Isododecane, Butylene Glycol, Acrylates/Polytrimethylsiloxymethacrylate Copolymer, Propanediol, Cyclohexasiloxane, Cetyl PEG/PPG-10/1 Dimethicone, Isodecyl Neopentanoate, Polymethylsilsesquioxane, Helianthus Annuus (Sunflower) Seed Oil, Disteardimonium Hectorite, Magnesium Sulfate, Schinziophyton Rautanenii (Mongongo) Kernel Oil, Phenoxyethanol, Disodium Stearoyl Glutamate, Caprylyl Glycol, Ethylene Brassylate, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Silica, Sorbitan Sesquioleate, Evodia Rutaecarpa (Wu-Zhu-Yu) Fruit Extract, Ethylhexylglycerin, Hexylene Glycol, Cellulose Gum, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Aluminum Hydroxide, Retinyl Palmitate, Rhodiola Rosea Root Extract, Sodium Hyaluronate, BHT, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopherol, Iron Oxides (CI 77491, CI 77492, CI 77499), Titanium Dioxide (CI 77891).

Package Label PDP

THE HEALTHY FOUNDATION  SPF 20
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69514-303
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)  
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
WATER (UNII: 059QF0KO0R)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
ISODODECANE (UNII: A8289P68Y2)  
PROPANEDIOL (UNII: 5965N8W85T)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
RHODIOLA ROSEA ROOT (UNII: 3S5ITS5ULN)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TOCOPHEROL (UNII: R0ZB2556P8)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TETRADIUM RUTICARPUM FRUIT (UNII: Q413WWJ3X9)  
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
SCHINZIOPHYTON RAUTANENII SEED OIL (UNII: 6GSJ7A6T1E)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
ROSEMARY (UNII: IJ67X351P9)  
DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF)  
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69514-303-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/202312/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/01/202312/01/2023
Labeler - Markwins Beauty Brands (078890119)

Revised: 12/2023
 

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