CALLYSSEE BEAUTY FACEGUARD SKIN PROTECTING FACIAL BALM- avobenzone, homosalate, octisalate, octocrylene, oxybenzone cream

callyssee by

Drug Labeling and Warnings

callyssee by is a Otc medication manufactured, distributed, or labeled by Emilia Personal Care Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Avobenzone (Butyl Methoxydibenzoylmethane) 3.0%

Homosalate, 10.0%

Octisalate, (Ehtylhexyl Salicylate) 5.0%

Octocrylene, 2.0%

Oxybenzone (Benzophenone-3) 4.0%

PURPOSE

Purpose

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Sunscreen

INDICATIONS & USAGE

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

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

Keep out of reach of children  -If swallowed, get medical help or contact

a Poison Control Center right away.

DOSAGE & ADMINISTRATION

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

Other information - protect the product in this container from

excessive heat and direct sun

INACTIVE INGREDIENT

Inactive ingredients:  isohexadecane, dimethicone/bis-isobutyl

PPG-20 crosspolymer, caprylic/capric triglyceride,

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

arabica seed extract

SPL UNCLASSIFIED SECTION

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CALLYSSEE  BEAUTY FACEGUARD SKIN PROTECTING FACIAL BALM
avobenzone, homosalate, octisalate, octocrylene, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42421-802
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.5 g  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.5 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1 g  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	2 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
ISOHEXADECANE (UNII: 918X1OUF1E)
DIMETHICONE (UNII: 92RU3N3Y1O)
BIS-ISOBUTYLENE PPG-20 (UNII: 5R9772B6IK)
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LEVOMENOL (UNII: 24WE03BX2T)
ARABICA COFFEE BEAN (UNII: 3SW678MX72)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42421-802-16	50 mL in 1 TUBE; Type 0: Not a Combination Product	12/26/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/26/2016

Labeler - Emilia Personal Care Inc (965445112)