BREATH FRESH SPF 15 BROAD SPECTRUM LIP BALM stick

Breath Fresh SPF 15 Broad Spectrum Lip Balm by

Drug Labeling and Warnings

Breath Fresh SPF 15 Broad Spectrum Lip Balm by is a Otc medication manufactured, distributed, or labeled by Raining Rose, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 2.0%

Octinoxate 6.5%

Octisalate 5.0%

Octocrylene 1.5%

Purpose

Sunscreen

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 well 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.

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

Inactive ingredients:

Sunflower oil*, Beeswax, Olive Oil*, Flavor, Hemp Seed Oil*, Rosemary Extract, Tocopherol, Aloe Vera Oil, Peppermint oil, Spearmint oil, Stevia*. * Organic

Package Label

INGREDIENTS AND APPEARANCE

BREATH FRESH SPF 15 BROAD SPECTRUM LIP BALM 
breath fresh spf 15 broad spectrum lip balm stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65692-0516
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.21 g  in 4.25 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.09 g  in 4.25 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.06 g  in 4.25 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.28 g  in 4.25 g

Inactive Ingredients
Ingredient Name	Strength
STEVIA LEAF (UNII: 6TC6NN0876)
PEPPERMINT OIL (UNII: AV092KU4JH)
SUNFLOWER OIL (UNII: 3W1JG795YI)
TOCOPHEROL (UNII: R0ZB2556P8)
ROSEMARY (UNII: IJ67X351P9)
WHITE WAX (UNII: 7G1J5DA97F)
OLIVE OIL (UNII: 6UYK2W1W1E)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SPEARMINT OIL (UNII: C3M81465G5)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65692-0516-1	4.25 g in 1 TUBE; Type 0: Not a Combination Product	02/17/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/17/2020

Labeler - Raining Rose, Inc (083819404)