FRE TINTED DEFENSE MOISTURIZER SPF15- octinoxate, titanium dioxide cream

FRE Tinted Defense Moisturizer SPF15 by

Drug Labeling and Warnings

FRE Tinted Defense Moisturizer SPF15 by is a Otc medication manufactured, distributed, or labeled by Emilia Cosmetics Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Octinoxate 4.0%

Titanium Dioxide 2.85%

PURPOSE

Purpose

sunscreen

sunscreen

INDICATIONS & USAGE

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

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

Keep out of reach of children. If

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

DOSAGE & ADMINISTRATION

Directions  apply liberally 15 minutes before sun exposure.  reapply at least

eveyr 2 hours.  use water resistant sunscreen if swimming or sweating.  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. 

STORAGE AND HANDLING

Other information  protect the product in this container from excessive heat 

and direct sun. 

INACTIVE INGREDIENT

Inactive ingredients  water, glycerin, potassium cetyl phosphate, argania

spinosa kernel oil, cyclopentasiloxane, glyceryl myristate, 

propanediol, behenyl alcohol, caprylic/capric/triglyceride, 

microcrystalline cellulose, cellulose gum, sodium

lactate, lactic acid, TEA-lactate, serine, urea, sorbitol, 

sodium chloride, allantoin, ascorbic acid, dimethicone,

phenoxyethanol, ethylhexylglycerin, argania spinosa leaf

extract, ammonium acryloyldimethyltaurate/VP coplymer, 

iron oxides, mica, buylene glycol, pentylene glycol, 

hydroxyphenyl propamidobenzoic acid, triethanolamine, 

fragrance, allantoin, trimethoxycaprylylsilane, disodium

EDTA, bisabolol, tocopheryl acetate (vitamin E), carnosine,

hyalurionic acid, chamomilla recutita (matricaria) flower

extract, tilia vulgaris (linden blossom) flower extract,

aspalathus linearis (rooibos) leaf extract, melissa officinalis

leaf extract.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FRE TINTED DEFENSE MOISTURIZER SPF15 
octinoxate, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43219-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.8 g  in 45 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.27 g  in 45 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
ARGAN OIL (UNII: 4V59G5UW9X)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCERYL MYRISTATE (UNII: 6992Y81827)
PROPANEDIOL (UNII: 5965N8W85T)
DOCOSANOL (UNII: 9G1OE216XY)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
SODIUM LACTATE (UNII: TU7HW0W0QT)
LACTIC ACID (UNII: 33X04XA5AT)
TRIETHANOLAMINE LACTATE (UNII: 064C51N81O)
SERINE (UNII: 452VLY9402)
UREA (UNII: 8W8T17847W)
SORBITOL (UNII: 506T60A25R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALLANTOIN (UNII: 344S277G0Z)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ARGANIA SPINOSA LEAF (UNII: 51XV5WTF7E)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)
TROLAMINE (UNII: 9O3K93S3TK)
TRIMETHOXYCAPRYLYLSILANE (UNII: FZ07E4LW2M)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
LEVOMENOL (UNII: 24WE03BX2T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HYALURONIC ACID (UNII: S270N0TRQY)
MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER)
TILIA X EUROPAEA FLOWER (UNII: NHV2K1OUDH)
ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43219-010-45	45 mL in 1 TUBE; Type 0: Not a Combination Product	09/06/2018	04/17/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/06/2018	04/17/2021

Labeler - Emilia Cosmetics Ltd (600076624)