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

Desert Spirit Lip Balm SPF 15 by

Drug Labeling and Warnings

Desert Spirit Lip Balm SPF 15 by is a Otc medication manufactured, distributed, or labeled by R & R Lotion, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active Ingredients

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

Purpose

Sunscreen

Uses

Helps prevent sunburn

Warnings

• 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.
• For external use only.

• 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

• Apply liberally 15 minutes before sun exposure
• Use a water resistant sunscreen if swimming or sweating
• Reapply at least every 2 hours
• Children under 6 months: Ask a doctor

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

SPL UNCLASSIFIED SECTION

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 - 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 - Desert Spirit

DESERT SPIRIT

SPF 15
Lip Protection

Net Wt. : 0.15 oz / 4.2 g

Peel label
for drug
facts info.

INGREDIENTS AND APPEARANCE

INDUSTRIAL LIP BALM SPF 15 
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59555-111
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	75 mg  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	30 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	YELLOW	Score
Shape		Size
Flavor	LIME (Lime Burst)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59555-111-20	4.2 g in 1 APPLICATOR; Type 0: Not a Combination Product	01/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	01/01/2020

CLEANROOM LIP BALM SPF 15 
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59555-112
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	75 mg  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	30 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	YELLOW	Score
Shape		Size
Flavor	LIME (Lime Burst)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59555-112-20	4.2 g in 1 APPLICATOR; Type 0: Not a Combination Product	01/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	01/01/2020

DESERT SPIRIT LIP BALM SPF 15 
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59555-113
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	75 mg  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	30 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	YELLOW	Score
Shape		Size
Flavor	LIME (Lime Burst)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59555-113-20	4.2 g in 1 APPLICATOR; Type 0: Not a Combination Product	01/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	01/01/2020

Labeler - R & R Lotion, Inc (062979000)