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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53040-995
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	3.5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53040-995-15	4 g in 1 TUBE; Type 0: Not a Combination Product	08/02/2012	12/31/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	08/02/2012	12/31/2019

Labeler - The Fresh Market (033041658)

Name	Address	ID/FEI	Business Operations
Establishment
Filltech USA, LLC		926433855	manufacture(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