BROAD SPECTRUM SPF 50 SUNSCREEN BIOELEMENTS- avobenzone, homosalate, ocinoxate, octisalate, octocrylene, oxybenzone cream

Broad Spectrum SPF 50 Sunscreen by

Drug Labeling and Warnings

Broad Spectrum SPF 50 Sunscreen 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

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 damaged or broken 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 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, Chamomille Recutita (Matricaria) Flower Extract, Chlorphenesin, Disodium EDTA, Glycerin, Nastartium Officiniale (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

Used in Professional Facials

SPF 50 FaceScreen

Broad Spectrum

SPF 50 Sunscreen

Daily antioxidant moisturizer

Decreases the risk of skin cancer and early skin aging caused by the sun when used as directed

68 mL/ 2.3 Fl. Oz.

INGREDIENTS AND APPEARANCE

BROAD SPECTRUM SPF 50 SUNSCREEN  BIOELEMENTS
avobenzone, homosalate, ocinoxate, octisalate, octocrylene, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49825-133
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ANGELICA SINENSIS ROOT (UNII: B66F4574UG)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
1,3-BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)
CHAMOMILE (UNII: FGL3685T2X)
CHLORPHENESIN (UNII: I670DAL4SZ)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
NASTURTIUM OFFICINALE (UNII: YH89GMV676)
ASIAN GINSENG (UNII: CUQ3A77YXI)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
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: 49825-133-02	1 in 1 BOX
1	NDC: 49825-133-01	68 mL in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	07/11/2013

Labeler - Bioelements (174813923)

Registrant - Bioelements (174813923)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Enterprises		017701475	manufacture(49825-133)