callyssee

Manufacturer
Emilia Personal Care Inc
Effective date
2021-11-04
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 22:29:27

Label at a glance#

Productcallyssee Beauty Faceguard Skin Protecting Facial Balm
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE
Label structure11 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

Avobenzone (Butyl Methoxydibenzoylmethane) 3.0%

Homosalate, 10.0%

Octisalate, (Ehtylhexyl Salicylate) 5.0%

Octocrylene, 2.0%

Oxybenzone (Benzophenone-3) 4.0%

OTC - PURPOSE SECTION

Purpose

Sunscreen

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 kin 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 two 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 witha 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:  isohexadecane, dimethicone/bis-isobutyl

PPG-20 crosspolymer, caprylic/capric triglyceride,

fragrance/parfum, tocopheryl acetate (vitamin E), bisabolol, coffee

arabica seed extract

OTC - QUESTIONS SECTION

Questions {or comments}?  1-844-331-1224

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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FDA-Initiated Inactive NDC Indexing#

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42421-80242421-802-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

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
fe52db42-2bf5-6877-e053-6294a90a8eb6ed9bab86-2ad2-419e-8d38-9ccdea0b00bb2023-06-17WarningsExact identifier
spl set id: ed9bab86-2ad2-419e-8d38-9ccdea0b00bb

Reported adverse events (FAERS/openFDA)#

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