FRE TINTED DEFENSE MOISTURIZER SPF15- octinoxate, titanium dioxide cream 
Emilia Cosmetics Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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FRE Tinted Defense Moisturizer SPF15

Active ingredients

Octinoxate 4.0%

Titanium Dioxide 2.85%

Purpose

sunscreen

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

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

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. 

Other information  •protect the product in this container from excessive heat 

and direct sun. 

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.

Label

FRE TINTED DEFENSE MOISTURIZER SPF15 
octinoxate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43219-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.8 g  in 45 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.27 g  in 45 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43219-010-4545 mL in 1 TUBE; Type 0: Not a Combination Product09/06/201804/17/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/06/201804/17/2021
Labeler - Emilia Cosmetics Ltd (600076624)

Revised: 5/2020
 
Emilia Cosmetics Ltd