THE HEALTHY FOUNDATION- octinoxate cream

The Healthy Foundation by

Drug Labeling and Warnings

The Healthy Foundation by is a Otc medication manufactured, distributed, or labeled by LINA GALE, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Octinoxate 3%

Purpose

Sunscreen

Uses

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

Warnings

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

Keep out of reach of children

If 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 the 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, expecially from 10 a.m. - 2 p.m.

wear long-sleeved shirts, pants, hats, and sunglasses

children under 6 months: Ask a doctor

Other information

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

Inactive ingredients

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

PDP

INGREDIENTS AND APPEARANCE

THE HEALTHY FOUNDATION 
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69514-133
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69514-133-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/10/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/10/2017

Labeler - LINA GALE, INC (078890119)