MOISTURIZING LIP BALMSPF30- avobenzone, homosalate, octisalate, octocrylene, oxybenzone stick

Moisturizing Lip BalmSPF30 by

Drug Labeling and Warnings

Moisturizing Lip BalmSPF30 by is a Otc medication manufactured, distributed, or labeled by AKG Innovations LLC, Englewood Labs LLC . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 2.5%

Homosalate 8.0%

Octisalate 5.0%       

Octocrylene 2.20%

Oxybenzone 3.0%

Purpose

Sunscreen

Uses

■Lip moisturizer: helps prevent sunburn.

Warnings

For external use only

When using this product keep out of eyes.

Rinse with water to remove - do not use on broken skin.

Keep out of reach of children.

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

Directions

■Apply liberally and evenly 15 minutes before sun exposure.

■Reapply at least every two hours.

■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 value of 15

or higher and other sun protection measures including:

limit time in the sun, especially from 10 AM – 2 PM

wear long sleeve shirts, pants, hats, and sunglasses

Inactive ingredients

Beeswax, Persea Gratissima

(Avocado) Oil, Butyrospermum Parkii (Shea)

Butter, Hydrogenated Vegetable Oil, Acacia

Decurrens/Jojoba/Sunflower Seed Wax Polyglyceryl-3

Esters, Menthyl Lactate, Argania Spinosa Kernel

Oil, Tocopheryl Acetate, Dimethicone, Helianthus

Annuus (Sunflower) Seed Oil Unsaponifiables, Aloe

Barbadensis Flower Extract, Bisabolol, Curcuma

Longa (Turmeric) Root Extract, Lawsonia Inermis

(Henna) Flower/Fruit/Leaf Extract, Melia Azadirachta

Flower Extract, Melia Azadirachta Leaf Extract,

Ocimum Basilicum (Basil) Flower/Leaf Extract,

Ocimum Sanctum Leaf Extract, Coccinia Indica

Fruit Extract, Corallina Officinalis Extract, Amino

Esters-1, Citrus Aurantium Dulcis (Orange) Peel Oil,

Simmondsia Chinensis (Jojoba) Seed Oil, Retinyl

Palmitate, Palmitoyl Oligopeptide, Ethylhexyl

Palmitate, Tribehenin, Sorbitan Isostearate, Menthol,

Caprylyl Glycol, Phenoxyethanol, Chlorphenesin.

Other information

■Protect from excessive heat and direct sun.

Questions or comments visit:

www.arthurglosmandentalbeauty.com

Or call 1.855.333.2544

MOISTURIZING LIP BALM SUNSCREEN BROAD SPECTRUM SPF-30 (

62111-0211-3)

advanced dental health - beauty

ARTHUR GLOSMAN DDS

        Beverly Hills

MOISTURIZING

LIP BALM

SUNSCREEN

BROAD

SPECTRUM

SPF-30

Net Wt. 0.15 oz. / 4.3 g

Distributed by:

AKG Innovations, LLC

450 N. Roxbury Drive,

Suite 222,

Beverly Hills, CA

90210

Made in USA

#90213

MOISTURIZING

LIP BALM

SPF-30

BROAD SPECTRUM

SUNSCREEN

Ice blue stick glides on smoothly,

leaving a soft sheen on the lips.

Cools with Menthol; moisturizes

with Avocado Oil, Shea Butter and

Jojoba Seed Oil; calms and soothes

with Dimethicone. UVA/UVB

SPF 30 protection to help prevent

sunburned lips. Can be used as

often as necessary on the lips and

around the lip area.

INGREDIENTS AND APPEARANCE

MOISTURIZING LIP BALMSPF30 
avobenzone, homosalate, octisalate, octocrylene, oxybenzone stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62111-0211
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	25 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	80 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	22.0 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	30 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX (UNII: 2ZA36H0S2V)
AVOCADO OIL (UNII: 6VNO72PFC1)
SHEA BUTTER (UNII: K49155WL9Y)
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
ARGAN OIL (UNII: 4V59G5UW9X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DIMETHICONE (UNII: 92RU3N3Y1O)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ALOE VERA FLOWER (UNII: 575DY8C1ER)
LEVOMENOL (UNII: 24WE03BX2T)
CURCUMA LONGA LEAF (UNII: H2HC4RY52C)
LAWSONIA INERMIS FLOWERING TOP (UNII: UF2093XE64)
AZADIRACHTA INDICA FLOWER (UNII: 3TE8A92UPM)
AZADIRACHTA INDICA LEAF (UNII: HKY915780T)
OCIMUM BASILICUM FLOWERING TOP (UNII: 7SAB275FP2)
OCIMUM TENUIFLORUM TOP (UNII: 34T63W8ULS)
COCCINIA GRANDIS FRUIT (UNII: VLJ6WOT3K5)
CORALLINA OFFICINALIS (UNII: 4004498D06)
CITRUS SINENSIS FLOWER OIL (UNII: AJ56JP5TFP)
JOJOBA OIL (UNII: 724GKU717M)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
Sorbitan Isostearate (UNII: 01S2G2C1E4)
MENTHOL (UNII: L7T10EIP3A)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CHLORPHENESIN (UNII: I670DAL4SZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62111-0211-3	1 in 1 BOX
1		4.3 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/06/2014

Labeler - AKG Innovations LLC (056576137)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Labs LLC		172198223	manufacture(62111-0211)