FRESH BLACK TEA AGE-DELAY BROAD SPECTRUM SUNSCREEN SPF 20- avobenzone, octinoxate, oxybenzone lotion

Fresh Black Tea Age-Delay Broad Spectrum Sunscreen SPF 20 by

Drug Labeling and Warnings

Fresh Black Tea Age-Delay Broad Spectrum Sunscreen SPF 20 by is a Otc medication manufactured, distributed, or labeled by Fresh, Inc., Bentley Laboratories, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Fresh Black Tea Age-Delay Lotion Broad Spectrum Sunscreen SPF 20

Active Ingredients

Avobenzone 1.80%
Octinoxate 7.49%
Oxybenzone 2.40%

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

For sunscreen use:

• Apply liberally 15 minutes before sun exposure
• Reapply at least every 2 hours
• Use a water resistant sunscreen if swimming or sweating
• 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

Other Information

Protect this product in container from excessive heat and direct sun

Inactive Ingredients

Aqua (Water), Isostearyl Neopentanoate, Glycerin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Glycine Soja (Soybean) Oil, Saccharomyces Ferment Filtrate, Camellia Sinensis Leaf Extract, Rubus Fruticosus (Blackberry) Leaf Extract, Litchi Chinensis Seed Extract, Adenosine, Tocopherol, Hydrogenated Lecithin, Parfum (Fragrance), Ethylhexyl Palmitate, Diethylhexyl Syringylidenemalonate, Potassium Sorbate, Sodium Benzoate, Butylene Glycol, Trisodium EDTA, Xanthan Gum, Sodium Hyaluronate, Maltodextrin, Hydrogenated Phosphatidylcholine, Polysorbate 60, Sorbitan Isostearate, BHT, Caprylic/Capric Triglyceride, Hydroxyethylcellulose, Sodium Citrate, Citric Acid, Biotin, Phenoxyethanol, Linalool (08235/Z)

Questions or Comments?

Call toll free 1(800)FRESH-20
Monday-Friday (9a.m. to 5p.m. EST )

Fresh Black Tea Age-Delay Lotion Broad Spectrum Sunscreen SPF 20 50ml (

42406-009-00)

INGREDIENTS AND APPEARANCE

FRESH BLACK TEA AGE-DELAY BROAD SPECTRUM SUNSCREEN SPF 20 
avobenzone, octinoxate, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42406-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	18 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	74.9 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	24 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
GLYCERIN (UNII: PDC6A3C0OX)
SOYBEAN OIL (UNII: 241ATL177A)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
RUBUS FRUTICOSUS LEAF (UNII: YQ2S06L8S9)
LITCHI CHINENSIS SEED (UNII: 9294024N9Q)
ADENOSINE (UNII: K72T3FS567)
TOCOPHEROL (UNII: R0ZB2556P8)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
EDETATE TRISODIUM (UNII: 420IP921MB)
XANTHAN GUM (UNII: TTV12P4NEE)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
POLYSORBATE 60 (UNII: CAL22UVI4M)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
BIOTIN (UNII: 6SO6U10H04)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
LINALOOL, (+/-)- (UNII: D81QY6I88E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42406-009-00	1 in 1 BOX	02/06/2014
1		50 mL in 1 BOTTLE, PUMP; 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	02/06/2014

Labeler - Fresh, Inc. (021403729)

Establishment
Name	Address	ID/FEI	Business Operations
Bentley Laboratories, LLC.		068351753	manufacture(42406-009)