FRE Protect Body Broad Spectrum SPF30

Manufacturer
Emilia Cosmetics Ltd
Effective date
2020-05-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:30:14

Label at a glance#

ProductFRE Protect Body Broad Spectrum SPF30
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure7 sections

Indications and uses

helps prevent sunburn if used as directed with other sun protection measures (see Directions ), decreases risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

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 Broad Spectrum SPF value of 15 or higher and other sun protection measures, i...

Label contents#

Full prescribing information#

Acitve Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone, 3%

Homosalate, 10%

Octisalate, 5%

Octocrylene, 10%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases risk of skin cancer and early skin aging caused by the sun.

Warnings

WARNINGS SECTION

For external use only

Do not use on 

OTC - DO NOT USE SECTION

damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove.

Stop use, and ask a doctor

OTC - STOP USE SECTION

if rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 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 shits, pants, hats and sunglasses.

Other Information

SPL UNCLASSIFIED SECTION

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

Inactive ingredients:

INACTIVE INGREDIENT SECTION

water, propanediol, coco-caprylate, diethylhexyl 2,6-naphthalate C12-15 alkyl benzoate, oryza sativa (rice) starch, phenoxyethanol, ethylhexylglycerin, tricontanyl PVP, glycerin, argania spinosa leaf extract, aloe barbadensis leaf juice, polyglyceryl-10 pentastearate, behenyl alcohol, sodium stearoyl lactylate, potassium cetyl phosphate, fragrace, xanthan gum, acrylate/C10-30 alkyl acrylate crosspolymer, allantoin, tocopheryl acetate (vitamin E), argania spinosa kernel oil, sodium phytate, butylene glycol, pentylene glycol, hydroxyphenyl propamidobenzoic acid, panthenol (pro-vitamin B5), sodium hydroxide, argania spinosa sprout cell extract, isomalt, lecithin, sodium benzoate.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43219-052-052023-06-18C16284748780-1f386c64a-012e-0266-e053-dadaa90a7c1aFRE Protect Body Broad Spectrum SPF30
43219-052-052023-01-30C16284748780-1f386c64a-012e-0266-e053-dadaa90a7c1aFRE Protect Body Broad Spectrum SPF30

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43219-05243219-052-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 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
fe69f941-5a9e-516b-e053-6294a90a83345afd790b-75e0-41ae-932f-b7e7cd07b2822023-06-18WarningsExact identifier
spl set id: 5afd790b-75e0-41ae-932f-b7e7cd07b282

Reported adverse events (FAERS/openFDA)#

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