HYDRADAY- octocrylene and avobenzone cream

Hydraday by

Drug Labeling and Warnings

Hydraday by is a Otc medication manufactured, distributed, or labeled by PF Invest Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients                                                               Purpose

Octocrylene 5% ................................................................. Sunscreen

Avobenzone (Butyl Methoxydibenzoyl Methane) 3% ......... Sunscreen

PURPOSE

Desheli

Diamond Treasure

Hydraday Face Moisturizer - Sunscreen SPF15

Based on Fytotigh™

Manufactured exclusively for Desheli by E.L Erman, Cosmetic Manufacturing, Ltd., 3 Haplada Street, P.O.B 12189 Ashdod, ISRAEL

Distributed: (US) PF Invest Company, Las Vegas, NV, 89101; 1-800-DeSheli (EU) PF Invest SIA, Reg.nr.40103686040, LV-1004, RIGA, LATVIA

Made in Israel

Other Information

Protect this product from excessive heat and direct sun

Questions or comments?

Call toll free 1-800-DeSheli M-F 8 a.m. - 5 p.m. (PST) desheli.com

50 ml e 1,69 fl.oz.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If product is swallowed get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Uses

Moisturizer cream provides deep hydration with UV protection for a beautiful, youth-inspired complexion. Nourishing antioxidants fight with free radicals, helps to protect the skin all day long against environmental aggressors.

WARNINGS

Warnings

Skin cancer/skin aging alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunbutn not skin cancer or early skin aging

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.

DOSAGE & ADMINISTRATION

Uses

Moisturizer cream provides deep hydration with UV protection for a beautiful, youth-inspired complexion. Nourishing antioxidants fight with free radicals, helps to protect the skin all day long against environmental aggressors.

INACTIVE INGREDIENT

Inactive Ingredients

Cetearyl alcohol, alpha hydroxy acid (fruit base), glycerin, sesame (sesamum indicum) seed oil, beeswax (cera alba), cetyl alcohol, aloe barbadensis leaf juice, FYTOTIGH™ (PhytoCell Tec™Argan (argania spinosa sprout cell extract & isomalt & lecithin & sodium benzoate & aqua/water), PhytoCell Tec™Solar Vitis (Grape (vitis vinifera) fruit cell extract & isomalt & lecithin & sodium benzoate & aqua/water), PhytoCell Tec™Malus Domestica (apple (pyrus malus) pectin extract & xanthan gum & glycerin & lecithin & phenoxyethanol & aqua/water & propanediol & hexapeptide-42)), phenoxyethanol, stearic acid, maris aqua (Dead Sea water), borage (borago officinalis) seed oil, gluconolactone, dog rose (rosa canina) fruit oil, dimethicone, shea butter (butyrospermum parkii), calendula officinalis flower oil, fragrance (parfum), sodium benzoate, chamomile (anthemis nobilis) flower extract, jojoba (simmondsia chinensis) seed oil, triethylene glycol, water (aqua) & glycerin & xanthan gum & diamond powder, evening primrose (oenothera biennis) oil, tocopheryl acetate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HYDRADAY 
octocrylene and avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61220-001(NDC: 43638-001)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.5 mg  in 50 mg
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.5 mg  in 50 mg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
SESAME OIL (UNII: QX10HYY4QV)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETYL ALCOHOL (UNII: 936JST6JCN)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARGANIA SPINOSA WHOLE (UNII: 83K6O4FR76)
ISOMALT (UNII: S870P55O2W)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
SODIUM BENZOATE (UNII: OJ245FE5EU)
MALUS DOMESTICA WHOLE (UNII: 04W636S1V3)
XANTHAN GUM (UNII: TTV12P4NEE)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARIC ACID (UNII: 4ELV7Z65AP)
BORAGO OFFICINALIS SEED (UNII: 2GXJ790US0)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
SHEA BUTTER (UNII: K49155WL9Y)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)
JOJOBA OIL (UNII: 724GKU717M)
TRIETHYLENE GLYCOL (UNII: 3P5SU53360)
DIAMOND (UNII: 6GRV67N0U2)
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61220-001-01	50 mg in 1 PACKAGE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/20/2013

Labeler - PF Invest Company (079180054)

Establishment
Name	Address	ID/FEI	Business Operations
PF Invest Company		079180054	relabel(61220-001)