OTC - ACTIVE INGREDIENT SECTION
Active ingredients
Avobenzon 3.0%
Homosalate, 8.0%
Octisalate, 4.0%
Octocrylene, 2.0%
Fre
- Manufacturer
- Emilia Personal Care Inc
- Effective date
- 2021-11-04
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:29:20
Label at a glance#
ProductFre Broad Spectrum
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure9 sections
Label contents#
Full prescribing information#
OTC - PURPOSE SECTION
Purpose
Sunscreen
Sunscreen
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
every 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
INACTIVE INGREDIENT SECTION
Inactive ingredients water, glycerin, styrene/acrylates copolymer, glyceryl
stearate, PEG-100 stearate, cetearyl alcohol, cetearyl glucoside, caprylyl methicone, dimethicone, trisiloxanane,
argania spinosa kernel oil, ascorbyl glucoside,
phenoxyethanol, ethylhexylglycerin, potassium cetyl
phosphate, hydrogenated palm glyceride, diethylhexyl
2,6-naphthalate, behenyl alcohol, argania spinosa leaf
extract, maltodextrin, panthenol (pro-vitamin B5), butylene
glycol, pentylene glycol, hydroxyphenol propamidobenzoic
acid, polymethyl methacrylate, fragrance, disodium EDTA,
xanthan gum, tocopheryl acetate (vitamin E), bisabolol,
camosine, BHT, retinyl palmitate (vitamin A), chamomilla
recutita (matricaria) flower extract, melissa officinalis leaf
extract, aspalathus linearis (rooibos) leaf extract, tilia
vulgaris (linden blossom) flower extract
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 42421-600-20 | 2023-06-17 | C162847 | 48780-1 | 9d75b9d1-123f-f424-e053-dadaa90a57ce | Fre Protect Me Defence Moisturizer |
| 42421-600-60 | 2023-06-17 | C162847 | 48780-1 | 9d75b9d1-123f-f424-e053-dadaa90a57ce | Fre Protect Me Defence Moisturizer |
| 42421-600-20 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d1-123f-f424-e053-dadaa90a57ce | Fre Protect Me Defence Moisturizer |
| 42421-600-60 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d1-123f-f424-e053-dadaa90a57ce | Fre Protect Me Defence Moisturizer |
| 42421-600-20 | 2020-05-18 | C162847 | 48780-1 | 9d75b9d1-123f-f424-e053-dadaa90a57ce | Fre Protect Me Defence Moisturizer |
| 42421-600-60 | 2020-05-18 | C162847 | 48780-1 | 9d75b9d1-123f-f424-e053-dadaa90a57ce | Fre Protect Me Defence Moisturizer |
| 42421-600-20 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-123f-f424-e053-dadaa90a57ce | Fre Protect Me Defence Moisturizer |
| 42421-600-60 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-123f-f424-e053-dadaa90a57ce | Fre Protect Me Defence Moisturizer |
Products#
Every source-derived product name is available through these pages.
- Fre Broad Spectrum
- AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
- WATER
- GLYCERIN
- STYRENE
- GLYCERYL MONOSTEARATE
- PEG-100 STEARATE
- CETOSTEARYL ALCOHOL
- CAPRYLYL TRISILOXANE
- DIMETHICONE
- TRISILOXANE
- ARGAN OIL
- ASCORBYL GLUCOSIDE
- PHENOXYETHANOL
- ETHYLHEXYLGLYCERIN
- POTASSIUM CETYL PHOSPHATE
- HYDROGENATED PALM GLYCERIDES
- DIETHYLHEXYL 2,6-NAPHTHALATE
- DOCOSANOL
- ARGANIA SPINOSA LEAF
- MALTODEXTRIN
- PANTHENOL
- BUTYLENE GLYCOL
- PENTYLENE GLYCOL
- HYDROXYPHENYL PROPAMIDOBENZOIC ACID
- POLY(METHYL METHACRYLATE; 450000 MW)
- EDETATE DISODIUM
- XANTHAN GUM
- .ALPHA.-TOCOPHEROL ACETATE
- LEVOMENOL
- BUTYLATED HYDROXYTOLUENE
- VITAMIN A PALMITATE
- CHAMOMILE
- MELISSA OFFICINALIS LEAF
- ASPALATHUS LINEARIS LEAF
- TILIA X EUROPAEA FLOWER
- CARNOSINE
- AVOBENZONE
- HOMOSALATE
- OCTISALATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 42421-600 | 42421-600-60, 42421-600-20 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| fe52d546-fd38-0939-e053-6294a90abddb | aeb0b914-db57-4c32-adf1-b6d0b355b3ab | 2023-06-17 | Warnings | aeb0b914-db57-4c32-adf1-b6d0b355b3ab |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.