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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

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)

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FRESH BLACK TEA AGE-DELAY BROAD SPECTRUM SUNSCREEN SPF 20 
avobenzone, octinoxate, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42406-009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE18 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE74.9 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE24 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42406-009-001 in 1 BOX02/06/201401/12/2021
150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/06/201401/12/2021
Labeler - Fresh, Inc. (021403729)
Establishment
NameAddressID/FEIBusiness Operations
Bentley Laboratories, LLC.068351753manufacture(42406-009)

Revised: 12/2021
 
Fresh, Inc.