FRE Tinted Defense Moisturizer SPF15

Manufacturer
Emilia Cosmetics Ltd
Effective date
2020-05-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:30:59

Label at a glance#

ProductFRE Tinted Defense Moisturizer SPF15
Active ingredientOCTINOXATE, TITANIUM DIOXIDE
Label structure9 sections

Storage and handling

Other information  •protect the product in this container from excessive heat  and direct sun. 

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Octinoxate 4.0%

Titanium Dioxide 2.85%

OTC - PURPOSE SECTION

Purpose

sunscreen

sunscreen

INDICATIONS & USAGE SECTION

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 SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If

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

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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

and direct sun. 

INACTIVE INGREDIENT SECTION

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43219-010-452020-02-17C16284748780-19d75b9d0-e7f7-f424-e053-dadaa90a57ceFRE Tinted Defense Moisturizer SPF15
43219-010-452020-01-31C16284748780-19d75b9d0-e7f7-f424-e053-dadaa90a57ceFRE Tinted Defense Moisturizer SPF15

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 44 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43219-01043219-010-45

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 42 matching rows.

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a58b0b70-e1c2-8c2d-e053-2995a90af835cba3c11f-a632-41fd-be25-b9066f31fcdd2020-05-13WarningsExact identifier
spl id: a58b0b70-e1c2-8c2d-e053-2995a90af835
spl set id: cba3c11f-a632-41fd-be25-b9066f31fcdd

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.