FACESCREEN SPF 50- avobenzone, homosalate, octinoxate, octisalate, octocrylene,oxybenzone liquid

Facescreen by

Drug Labeling and Warnings

Facescreen by is a Otc medication manufactured, distributed, or labeled by Bioelements, Cosmetic Enterprises. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients            Purpose

Avobenzone 3.0%            Sunscreen

Homosalate 10%              Sunscreen

Octinoxate 7.0%               Sunscreen

Octisalate 5.0%                Sunscreen

Octocrylene 5.0%             Sunscreen

Oxybenzone 6.0%             Sunscreen

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.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if rash occurs

Warnings

For external use only

Do not use on broken or damaged skin

When using this product Keep out of eyes. Rinse with water to remove.

Directions

Apply liberally 15 minutes before sun exposure

Use a water resistant sunscreen if swimming or sweating

Reapply at least every 2 hours

Children under 6 months: 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 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-sleeve shirts, pants, hats, and sunglasses

Acrylates/C10-30 Alyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice Powder, Angelica Polymorpha Sinensis (Dong Quai) Root Extract, Ascorbyl Palmitate, Butylene Glycol, Centella Asiatica (Gotu Kola) Extract, Cetyl Dimethicone, Chamomile Recutita  (Matricaria) Flower Extract, Chlorphenesin, Disodium EDTA, Glycerin, Nastartium Officinale (Watercress) Extract, Panax Ginseng (Ginseng) Root Extract, Phenoxyethanol, Phospholipids, Retinyl Palmitate, Rhus Glabra (Sumac) Extract, Steareth-2, Steareth-21, Tocopheryl Acetate, Triethanolamine, Water (Aqua,Eau)

PRINCIPAL DISPLAY PANEL

Bioelements

SPF 50 FaceScreen

Broad Spectrum SPF 50 Sunscreen

68 mL/ 2.3 Fl. Oz.

INGREDIENTS AND APPEARANCE

FACESCREEN  SPF 50
avobenzone, homosalate, octinoxate, octisalate, octocrylene,oxybenzone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49825-122
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3.0 mL  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 mL  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.0 mL  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5.0 mL  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5.0 mL  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	6.0 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) (UNII: 59TL3WG5CO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ANGELICA SINENSIS ROOT (UNII: B66F4574UG)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
CHAMOMILE (UNII: FGL3685T2X)
CHLORPHENESIN (UNII: I670DAL4SZ)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
ASIAN GINSENG (UNII: CUQ3A77YXI)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
RHUS GLABRA BARK (UNII: 7XC0E9WP6U)
STEARETH-2 (UNII: V56DFE46J5)
STEARETH-21 (UNII: 53J3F32P58)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49825-122-02	1 in 1 CARTON
1	NDC: 49825-122-01	68 mL in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/23/2012

Labeler - Bioelements (174813923)

Registrant - Bioelements (174813923)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Enterprises		017701475	manufacture