BULLET LINE- lip balm spf 15 stick

Bullet Line by

Drug Labeling and Warnings

Bullet Line by is a Otc medication manufactured, distributed, or labeled by Raining Rose, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

PURPOSE

Purpose

INDICATIONS & USAGE

Uses

WARNINGS

Warnings:
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

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

DOSAGE & ADMINISTRATION

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 of age: Ask a doctor

OTHER SAFETY INFORMATION

Sun Protection Measures Spending time in the sun increases your
risk of skin cancer and early skin aging. To decrease this risk, regularly
use a sunscreen with a Broad-Spectrum SPF value of 15 or higher and
other protection measures including: limit time in the sun, especially from
10a.m. - 2p.m. wear long sleeved shirts, pants, hat, and sunglasses.

INACTIVE INGREDIENT

Inactive ingredients: Mineral oil, Beeswax, Petrolatum, Paraffin

Ethylhexyl Palmitate, Ceresin, Cetyl Alcohol, Tocopheryl Acetate, Propylparaben, Aloe Juice.

OTHER SAFETY INFORMATION

Other Information
Protect this product from excessive heat and direct sun.

Package Labeling

Twist Cap to Break Seal

​Broad Spectrum SPF 15 Sunscreen

Mfg. for Bullet, Hialeah, FL  33013

Made in the USA

Net Wt. .15 oz.

No-flavor

Berry

Cherry

Mint

Strawberry

Tropical

Vanilla

res

INGREDIENTS AND APPEARANCE

BULLET LINE 
lip balm spf 15 stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65692-1006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.0 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6.5 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5.0 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
WHITE WAX (UNII: 7G1J5DA97F)
YELLOW WAX (UNII: 2ZA36H0S2V)
PETROLATUM (UNII: 4T6H12BN9U)
PARAFFIN (UNII: I9O0E3H2ZE)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CERESIN (UNII: Q1LS2UJO3A)
CETYL ALCOHOL (UNII: 936JST6JCN)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65692-1006-1	4 g in 1 TUBE; Type 0: Not a Combination Product	02/18/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/18/2020

BULLET LINE 
lip balm spf 15 stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65692-1007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.0 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6.5 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5.0 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
YELLOW WAX (UNII: 2ZA36H0S2V)
PETROLATUM (UNII: 4T6H12BN9U)
PARAFFIN (UNII: I9O0E3H2ZE)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CERESIN (UNII: Q1LS2UJO3A)
CETYL ALCOHOL (UNII: 936JST6JCN)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Product Characteristics
Color		Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65692-1007-1	4 g in 1 TUBE; Type 0: Not a Combination Product	02/18/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/18/2020

BULLET LINE 
lip balm spf 15 stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65692-1008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.0 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6.5 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5.0 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
YELLOW WAX (UNII: 2ZA36H0S2V)
PETROLATUM (UNII: 4T6H12BN9U)
PARAFFIN (UNII: I9O0E3H2ZE)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CERESIN (UNII: Q1LS2UJO3A)
CETYL ALCOHOL (UNII: 936JST6JCN)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65692-1008-1	4 g in 1 TUBE; Type 0: Not a Combination Product	02/18/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/18/2020

BULLET LINE 
lip balm spf 15 stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65692-1009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.0 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6.5 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5.0 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
YELLOW WAX (UNII: 2ZA36H0S2V)
PETROLATUM (UNII: 4T6H12BN9U)
PARAFFIN (UNII: I9O0E3H2ZE)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CERESIN (UNII: Q1LS2UJO3A)
CETYL ALCOHOL (UNII: 936JST6JCN)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65692-1009-1	4 g in 1 TUBE; Type 0: Not a Combination Product	02/18/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/18/2020

BULLET LINE 
lip balm spf 15 stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65692-1010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.0 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6.5 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5.0 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
YELLOW WAX (UNII: 2ZA36H0S2V)
PETROLATUM (UNII: 4T6H12BN9U)
PARAFFIN (UNII: I9O0E3H2ZE)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CERESIN (UNII: Q1LS2UJO3A)
CETYL ALCOHOL (UNII: 936JST6JCN)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Product Characteristics
Color		Score
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65692-1010-1	4 g in 1 TUBE; Type 0: Not a Combination Product	02/18/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/18/2020

BULLET LINE 
lip balm spf 15 stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65692-1011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.0 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6.5 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5.0 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
YELLOW WAX (UNII: 2ZA36H0S2V)
PETROLATUM (UNII: 4T6H12BN9U)
PARAFFIN (UNII: I9O0E3H2ZE)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CERESIN (UNII: Q1LS2UJO3A)
CETYL ALCOHOL (UNII: 936JST6JCN)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Product Characteristics
Color		Score
Shape		Size
Flavor	TROPICAL FRUIT PUNCH (TROPICAL)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65692-1011-1	4 g in 1 TUBE; Type 0: Not a Combination Product	02/18/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/18/2020

BULLET LINE 
lip balm spf 15 stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65692-1012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.0 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6.5 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5.0 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
YELLOW WAX (UNII: 2ZA36H0S2V)
PETROLATUM (UNII: 4T6H12BN9U)
PARAFFIN (UNII: I9O0E3H2ZE)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CERESIN (UNII: Q1LS2UJO3A)
CETYL ALCOHOL (UNII: 936JST6JCN)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Product Characteristics
Color		Score
Shape		Size
Flavor	VANILLA	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65692-1012-1	4 g in 1 TUBE; Type 0: Not a Combination Product	02/18/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/18/2020

Labeler - Raining Rose, Inc (083819404)