INDUSTRIAL LIP BALM SPF 15- octinoxate and oxybenzone lipstick 
CLEANROOM LIP BALM SPF 15- octinoxate and oxybenzone lipstick 
DESERT SPIRIT LIP BALM SPF 15- octinoxate and oxybenzone lipstick 
R & R Lotion, 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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Lip Balm SPF 15

DRUG FACTS

Active Ingredients

Benzophenone-3 (Oxybenzone) 3%
Ethylhexyl Methoxycinnamate (Octinoxate) 7.5%

Purpose

Sunscreen

Uses

Helps prevent sunburn

Warnings

  • Do not use on damaged or broken skin.

  • Stop use and ask a doctor if rash occurs.

  • When using this product keep out of eyes. Rinse with water to remove.

  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive Ingredients

Aloe Barbadensis (Aloe Vera) Leaf Extract, Copernicia Cerifera (Carnauba) Wax, Flavor, Mineral Oil, Paraffin, Petrolatum, Retinyl Palmitate, Simmondsia Chinensis (Jojoba) Seed Oil, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol (Vitamin E), Zea Mays (Corn) Oil (and) BHA (and) Propyl Gallate (and) Citric Acid.

Other Information

Protect this product from excessive heat and direct sun

Questions or comments?

Call 1-262-268-2720

Manufactured by: Alliance Packaging Group, Inc. Saukville, WI 53080

PRINCIPAL DISPLAY PANEL - 4.2 g Applicator Label - Industrial

INDUSTRIAL
LIPBALM
SPF 15

LIME BURST
LIP BALM

PN# ISLB

Net Wt. : 0.15 oz / 4.2 g

Peel label
for drug
facts info.

PRINCIPAL DISPLAY PANEL - 4.2 g Applicator Label - Industrial

PRINCIPAL DISPLAY PANEL - 4.2 g Applicator Label - Clean Balm

Peel label
for drug
facts info.

R&R
LOTION®
I.C. CLEAN BALM SPF 15 ™

LIME BURST
LIP BALM

PN# ISLB

Net Wt. : 0.15 oz / 4.2 g

PRINCIPAL DISPLAY PANEL - 4.2 g Applicator Label - Clean Balm

PRINCIPAL DISPLAY PANEL - 4.2 g Applicator Label - Desert Spirit

DESERT SPIRIT

SPF 15
Lip Protection

Net Wt. : 0.15 oz / 4.2 g

Peel label
for drug
facts info.

PRINCIPAL DISPLAY PANEL - 4.2 g Applicator Label - Desert Spirit
INDUSTRIAL LIP BALM SPF 15 
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59555-111
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate75 mg  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone30 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Carnauba Wax (UNII: R12CBM0EIZ)  
Mineral Oil (UNII: T5L8T28FGP)  
Paraffin (UNII: I9O0E3H2ZE)  
Petrolatum (UNII: 4T6H12BN9U)  
Vitamin A Palmitate (UNII: 1D1K0N0VVC)  
Jojoba Oil (UNII: 724GKU717M)  
Cocoa Butter (UNII: 512OYT1CRR)  
Corn Oil (UNII: 8470G57WFM)  
Propyl Gallate (UNII: 8D4SNN7V92)  
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
Product Characteristics
ColorYELLOWScore    
ShapeSize
FlavorLIME (Lime Burst) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59555-111-204.2 g in 1 APPLICATOR; Type 0: Not a Combination Product01/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35201/01/2020
CLEANROOM LIP BALM SPF 15 
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59555-112
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate75 mg  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone30 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Carnauba Wax (UNII: R12CBM0EIZ)  
Mineral Oil (UNII: T5L8T28FGP)  
Paraffin (UNII: I9O0E3H2ZE)  
Petrolatum (UNII: 4T6H12BN9U)  
Vitamin A Palmitate (UNII: 1D1K0N0VVC)  
Jojoba Oil (UNII: 724GKU717M)  
Cocoa Butter (UNII: 512OYT1CRR)  
Corn Oil (UNII: 8470G57WFM)  
Propyl Gallate (UNII: 8D4SNN7V92)  
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
Product Characteristics
ColorYELLOWScore    
ShapeSize
FlavorLIME (Lime Burst) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59555-112-204.2 g in 1 APPLICATOR; Type 0: Not a Combination Product01/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35201/01/2020
DESERT SPIRIT LIP BALM SPF 15 
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59555-113
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate75 mg  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone30 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Carnauba Wax (UNII: R12CBM0EIZ)  
Mineral Oil (UNII: T5L8T28FGP)  
Paraffin (UNII: I9O0E3H2ZE)  
Petrolatum (UNII: 4T6H12BN9U)  
Vitamin A Palmitate (UNII: 1D1K0N0VVC)  
Jojoba Oil (UNII: 724GKU717M)  
Cocoa Butter (UNII: 512OYT1CRR)  
Corn Oil (UNII: 8470G57WFM)  
Propyl Gallate (UNII: 8D4SNN7V92)  
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
Product Characteristics
ColorYELLOWScore    
ShapeSize
FlavorLIME (Lime Burst) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59555-113-204.2 g in 1 APPLICATOR; Type 0: Not a Combination Product01/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35201/01/2020
Labeler - R & R Lotion, Inc (062979000)

Revised: 10/2020
Document Id: bda160ee-9bb4-4fbd-86d6-355cc7f39b28
Set id: 28942754-8f2c-442b-abc9-113c2f0982b6
Version: 1
Effective Time: 20201020
 
R & R Lotion, Inc