CELLULAR LABORATORIES DE-AGING SUNSCREEN BROAD SPECTRUM SPF 50 PLUS- homosalate, octisalate, avobenzone, octocrylene cream

Cellular Laboratories De-Aging Sunscreen Broad Spectrum SPF 50 Plus by

Drug Labeling and Warnings

Cellular Laboratories De-Aging Sunscreen Broad Spectrum SPF 50 Plus by is a Otc medication manufactured, distributed, or labeled by Market America, Englewood Lab, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Cellular Laboratories De-Aging Sunscreen Broad Spectrum SPF 50+

Active Ingredients

Homosalate  10.0%
Octisalate  5.0%
Avobenzone 3.0%
Octocrylene  2.6%

Purpose

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
  

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.

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

Directions

• Apply liberally 15 minutes before sun exposure.
• Use a water-resistant sunscreen if swimming or sweating.
• Reapply:  - at least every 2 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 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.
• Children under 6 months:  Ask a doctor.
  

Other Information

Sun Alert:  Protect this product from excessive heat and direct sun.

Inactive Ingredients

Water, Dipropylene Glycol, Dicaprylyl Carbonate, Caprylyl Methicone, PEG/PPG-17/6 Copolymer, Alcohol, Polyacrylate-15, Methyl Glucose Sesqui-stearate, Cetyl Alcohol, Butylene Glycol, Caprylic/Capric Triglyceride, Isohexadecane, Potassium Cetyl Phosphate, Glyceryl Stearate, PEG-100 Stearate, PEG-10 Dimethicone, Adenosine, Teprenone, Lonicera caprifolium (honeysuckle) Flower Extract, Zizyphus jujuba Fruit Extract, Glycyrrhiza glabra (licorice) Root Extract, Camellia sinensis (green tea) Leaf Extract, Dipotassium Glycyrrhizate, Hydrogenated Palm Glycerides, Polyacrylate-17, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polysorbate 80, Panthenol, Tocopheryl Acetate, Disodium EDTA, Potassium Hydroxide, Phenoxyethanol, Caprylyl Glycol, Fragrance.

SPL UNCLASSIFIED SECTION

Protect yourself from the sun with this comprehensive blend of four active sunscreen ingredients, in conjunction with vitamin E and greet tea extracts, for a vibrant glow for your face and entire body.  Manufactured for and extensively distributed in the U.S. by:  Market America, Inc. 1302 Pleasant Ridge Road, Greensboro, NC 27409

PRINCIPAL DISPLAY PANEL

cellular laboratories   De-Aging Sunscreen Broad Spectrum SPF 50+   net vol. 3.4 fl. oz/100 mL

Cellular Laboratories De-Aging Sunscreen Broad Spectrum SPF 50+ 100ml (

76209-123-01)

INGREDIENTS AND APPEARANCE

CELLULAR LABORATORIES DE-AGING SUNSCREEN BROAD SPECTRUM SPF 50 PLUS  
homosalate, octisalate, avobenzone, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76209-123
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	26 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
PEG/PPG-17/6 COPOLYMER (UNII: P5QZM4T259)
ALCOHOL (UNII: 3K9958V90M)
CETYL ALCOHOL (UNII: 936JST6JCN)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ISOHEXADECANE (UNII: 918X1OUF1E)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
ADENOSINE (UNII: K72T3FS567)
TEPRENONE (UNII: S8S8451A4O)
LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)
JUJUBE FRUIT (UNII: G55HNL2C70)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PANTHENOL (UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76209-123-01	1 in 1 CARTON	12/19/2017
1		100 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/03/2011

Labeler - Market America (797412236)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Lab, Inc.		080366903	manufacture(76209-123)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Lab Korea Co., Ltd.		690104005	manufacture(76209-123)