BITE BEAUTY- octinoxate and oxybenzone ointment 
Susanne Lang Fragrance 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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Bite Beauty

Active Ingredients

Octinoxate (Sunscreen) 7.50%,

Oxybenzone (Sunscreen) 3.00%

Purpose

Sunscreen

Use

Helps prevent sunburn

Warning

Skin Cancer/Skin Aging Alert

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging

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

Directions

Apply generously and evenly 15 minutes before sun exposure

Children under 6 months of age: Ask a doctor

For external use only

Protect the product in this container from excessive heat and direct sun

Other Ingredients

ORGANIC RICINUS COMMUNIS (CASTOR) SEED OIL**, POLYGLYCERYL-2 TRIISOSTEARATE* (VEGETABLE DERIVED)*, ORGANIC CERA ALBA (BEESWAX)**, CAPRYLIC/CAPRIC TRIGLYCERIDE (AND) PHYTOSTERYL CANOLA GLYCERIDES (AND) POLYGLYCERYL-3 DIISOSTEARATE (AND) PHOSPHOLIPIDS (AND) TOCOPHEROL ACETATE*, ORGANIC ARGANIA SPINOSA (ARGAN) KERNEL OIL**, ORGANIC SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL**, TOCOPHERYL ACETATE (AND) BISABOLOL*, ORGANIC BUTYROSPERMUM PARKII (SHEA) BUTTER**, ORGANIC COPERNICIACERIFERA (CARNAUBA) WAX**, OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES*, NATURAL FLAVOR*, RHUS SUCCEDANEA FRUIT WAX*, HYDROGENATED OLIVE OIL UNSAPONIFIABLES*, TRANSRESVERATROL*, VITIS VINEFERA (GRAPESEED) OIL*, SIRAITIA GROSVENORI (MONK FRUIT)*

May Contain

MICA (CI 77019)*, TITANIUM DIOXIDE (CI 77891)*, IRON OXIDES (CI 77491, CI 77492, CI 77499)*, CARMINE (CI 75470)*, FD&C BLUE NO. 1 (CI 42090), FD&C YELLOW NO. 5 (CI 19140), FD&C YELLOW NO. 6 (CI 15985), FD&C RED NO. 40 (CI 16035), D&C RED 6 (CI 15850), D&C RED 7 (CI 15850), MANGANESE VIOLET (CI 77742)*

*NATURAL
** CERTIFIED ORGANIC

Package/Label Principal Display Panel - Dolce

Bite
Beauty

Natural
Food Grade

SPF 15
BB for Lips
with Resveratrol

Net Wt.
.12 oz 3.52 g

Dist. By
Bite Beauty
Toronto
Canada M6H 4H1
London
UK SW7 2SS
Made in Canada

Dolce Carton Label

Dolce Carton Label

Package/Label Principal Display Panel - Flush

Bite
Beauty

Natural
Food Grade

SPF 15
BB For Lips
with Resveratrol

Net Wt.
.12 oz 3.52g

Dist. By
Bite Beauty
Toronto
Canada M6H 4H1
London
UK SW7 2SS
Made in Canada

Flush Carton Label

Flush Carton Label

Package/Label Principal Display Panel - Natural

Bite
Beauty

Natural
Food Grade

SPF 15
BB for Lips
with Resveratrol

Net Wt.
.12 oz 3.52g

Dist. By
Bite Beauty
Toronto
Canada M6H 4H1
London
UK SW7 2SS
Made in Canada

Natural Carton Label

Natural Carton Label

Package/Label Principal Display Panel - Suede

Bite
Beauty

Natural
Food Grade

SPF 15
BB for Lips
with Resveratrol

Net Wt.
.12 oz 3.52g

Dist. By
Bite Beauty
Toronto
Canada M6H 4H1
London
UK SW7 2SS
Made in Canada

Suede Carton Label

Suede Carton Label

Package/Label Principal Display Panel - Tawny

Bite
Beauty

Natural
Food Grade

SPF 15
BB for Lips
with Resveratrol

Net Wt.
.12 oz 3.52g

Dist. By
Bite Beauty
Toronto
Canada M6H 4H1
London
UK SW7 2SS
Made in Canada

Tawny Carton Label

Tawny Carton Label

BITE BEAUTY 
octinoxate, oxybenzone ointment
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:47202-1501
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE7.5 g  in 100 g
OXYBENZONE (OXYBENZONE) OXYBENZONE3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
RICINUS COMMUNIS SEED 
POLYGLYCERYL-2 MONOISOSTEARATE 
YELLOW WAX 
ARGAN OIL 
JOJOBA OIL 
.ALPHA.-TOCOPHEROL 
SHEA BUTTER 
CARNAUBA WAX 
OLIVE OIL 
TOXICODENDRON SUCCEDANEUM WHOLE 
CANDELILLA WAX 
RESVERATROL 
GRAPE SEED OIL 
SIRAITIA GROSVENORII FRUIT 
MICA 
TITANIUM DIOXIDE 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
CARMINIC ACID 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 5 
FD&C YELLOW NO. 6 
FD&C RED NO. 40 
D&C RED NO. 6 
D&C RED NO. 7 
MANGANESE VIOLET 
MEDIUM-CHAIN TRIGLYCERIDES 
POLYGLYCERYL-3 DIISOSTEARATE 
OMEGA-3 FATTY ACIDS 
LEVOMENOL 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:47202-1501-13.52 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/13/2014
BITE BEAUTY 
octinoxate, oxybenzone ointment
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:47202-1502
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE7.5 g  in 100 g
OXYBENZONE (OXYBENZONE) OXYBENZONE3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
RICINUS COMMUNIS SEED 
POLYGLYCERYL-2 MONOISOSTEARATE 
YELLOW WAX 
ARGAN OIL 
JOJOBA OIL 
.ALPHA.-TOCOPHEROL 
SHEA BUTTER 
CARNAUBA WAX 
OLIVE OIL 
TOXICODENDRON SUCCEDANEUM WHOLE 
CANDELILLA WAX 
RESVERATROL 
GRAPE SEED OIL 
SIRAITIA GROSVENORII FRUIT 
MICA 
TITANIUM DIOXIDE 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
CARMINIC ACID 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 5 
FD&C YELLOW NO. 6 
FD&C RED NO. 40 
D&C RED NO. 6 
D&C RED NO. 7 
MANGANESE VIOLET 
MEDIUM-CHAIN TRIGLYCERIDES 
POLYGLYCERYL-3 DIISOSTEARATE 
OMEGA-3 FATTY ACIDS 
LEVOMENOL 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:47202-1502-13.52 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/13/2014
BITE BEAUTY 
octinoxate, oxybenzone ointment
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:47202-1503
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE7.5 g  in 100 g
OXYBENZONE (OXYBENZONE) OXYBENZONE3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
RICINUS COMMUNIS SEED 
POLYGLYCERYL-2 MONOISOSTEARATE 
YELLOW WAX 
ARGAN OIL 
JOJOBA OIL 
.ALPHA.-TOCOPHEROL 
SHEA BUTTER 
CARNAUBA WAX 
OLIVE OIL 
TOXICODENDRON SUCCEDANEUM WHOLE 
CANDELILLA WAX 
RESVERATROL 
GRAPE SEED OIL 
SIRAITIA GROSVENORII FRUIT 
MICA 
TITANIUM DIOXIDE 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
CARMINIC ACID 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 5 
FD&C YELLOW NO. 6 
FD&C RED NO. 40 
D&C RED NO. 6 
D&C RED NO. 7 
MANGANESE VIOLET 
MEDIUM-CHAIN TRIGLYCERIDES 
POLYGLYCERYL-3 DIISOSTEARATE 
OMEGA-3 FATTY ACIDS 
LEVOMENOL 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:47202-1503-13.52 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/13/2014
BITE BEAUTY 
octinoxate, oxybenzone ointment
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:47202-1504
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE7.5 g  in 100 g
OXYBENZONE (OXYBENZONE) OXYBENZONE3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
RICINUS COMMUNIS SEED 
POLYGLYCERYL-2 MONOISOSTEARATE 
YELLOW WAX 
ARGAN OIL 
JOJOBA OIL 
.ALPHA.-TOCOPHEROL 
SHEA BUTTER 
CARNAUBA WAX 
OLIVE OIL 
TOXICODENDRON SUCCEDANEUM WHOLE 
CANDELILLA WAX 
RESVERATROL 
GRAPE SEED OIL 
SIRAITIA GROSVENORII FRUIT 
MICA 
TITANIUM DIOXIDE 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
CARMINIC ACID 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 5 
FD&C YELLOW NO. 6 
FD&C RED NO. 40 
D&C RED NO. 6 
D&C RED NO. 7 
MANGANESE VIOLET 
MEDIUM-CHAIN TRIGLYCERIDES 
POLYGLYCERYL-3 DIISOSTEARATE 
OMEGA-3 FATTY ACIDS 
LEVOMENOL 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:47202-1504-13.52 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/13/2014
BITE BEAUTY 
octinoxate, oxybenzone ointment
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:47202-1505
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE7.5 g  in 100 g
OXYBENZONE (OXYBENZONE) OXYBENZONE3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
RICINUS COMMUNIS SEED 
POLYGLYCERYL-2 MONOISOSTEARATE 
YELLOW WAX 
ARGAN OIL 
JOJOBA OIL 
.ALPHA.-TOCOPHEROL 
SHEA BUTTER 
CARNAUBA WAX 
OLIVE OIL 
TOXICODENDRON SUCCEDANEUM WHOLE 
CANDELILLA WAX 
RESVERATROL 
GRAPE SEED OIL 
SIRAITIA GROSVENORII FRUIT 
MICA 
TITANIUM DIOXIDE 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
CARMINIC ACID 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 5 
FD&C YELLOW NO. 6 
FD&C RED NO. 40 
D&C RED NO. 6 
D&C RED NO. 7 
MANGANESE VIOLET 
MEDIUM-CHAIN TRIGLYCERIDES 
POLYGLYCERYL-3 DIISOSTEARATE 
OMEGA-3 FATTY ACIDS 
LEVOMENOL 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:47202-1505-13.52 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/13/2014
Labeler - Susanne Lang Fragrance Inc. (209553648)

Revised: 2/2014
Document Id: 72d3b3d8-61bd-493d-8d63-807b60fccb3b
Set id: 72d3b3d8-61bd-493d-8d63-807b60fccb3b
Version: 1
Effective Time: 20140221
 
Susanne Lang Fragrance Inc.