The Fresh Market SPF 15 Lip Balm Broad Spectrum Acai Berry

The Fresh Market SPF 15 Lip Balm Broad Spectrum Acai Berry by

Drug Labeling and Warnings

The Fresh Market SPF 15 Lip Balm Broad Spectrum Acai Berry by is a Otc medication manufactured, distributed, or labeled by The Fresh Market, Filltech USA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

THE FRESH MARKET SPF 15 LIP BALM BROAD SPECTRUM ACAI BERRY- avobenzone, octinoxate, oxybenzone stick 
The Fresh Market

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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The Fresh Market SPF 15 Lip Balm Broad Spectrum Acai Berry

Drug Facts


Active Ingredients:

Avobenzone (2%)
Octinoxate (7.5%)
Oxybenzone (3.5%)

Purpose

Sunscreen

Uses:

  • Lip Moisturizer
  • Sunscreen

Warnings:

For external use only.

When using this product

avoid contact with eyes.

Stop use

and consult a physician if irritation or rash occurs.

Keep out of reach of children


Directions:

Apply evenly to lips often and especially prior to sun exposure.

Inactive Ingredients:

cera alba (beeswax), cocos nucifera (coconut) oil, flavour, helianthus annuus (sunflower) seed oil, lanolin, persea gratissima (avocado) oil, simmondsia chinensis (jojoba) seed oil, saccharin, tocopherol (vitamin e), vitis vinifera (grapeseed) oil

Questions?

Call 866-817-4367

THE FRESH MARKET SPF 15 LIP BALM MOISTURIZED AND PROTECTS BROAD SPECTRUM SPF 15 ACAI BERRY net wt.0.15 oz(4g)

Product Label

SPF 15 Lip Balm

THE FRESH MARKET SPF 15 LIP BALM BROAD SPECTRUM ACAI BERRY 
avobenzone, octinoxate, oxybenzone stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 53040-995
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE3.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
YELLOW WAX (UNII: 2ZA36H0S2V)  
COCONUT OIL (UNII: Q9L0O73W7L)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
LANOLIN (UNII: 7EV65EAW6H)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
JOJOBA OIL (UNII: 724GKU717M)  
SACCHARIN (UNII: FST467XS7D)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 53040-995-154 g in 1 TUBE; Type 0: Not a Combination Product08/02/201212/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/02/201212/31/2019
Labeler - The Fresh Market (033041658)
Establishment
NameAddressID/FEIBusiness Operations
Filltech USA, LLC926433855manufacture(53040-995)

Revised: 11/2019
Document Id: 982f7873-09b0-2bef-e053-2a95a90ac783
Set id: 713cdabb-aea1-42a4-8918-9659ed37d4aa
Version: 3
Effective Time: 20191125
 
The Fresh Market