CHOCOLATE COFFEE STOUT SPF 15 BROAD SPECTRUM LIP BALM- chocolate coffee stout spf 15 broad spectrum lip balm stick
Raining Rose, 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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Chocolate Coffee Stout SPF 15 Lip Balm

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, Canola Oil. * Organic

Package Label

C10826 SPF 15 BS Chocolate Coffee Stout

CHOCOLATE COFFEE STOUT SPF 15 BROAD SPECTRUM LIP BALM
chocolate coffee stout spf 15 broad spectrum lip balm stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65692-0504
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
CANOLA OIL (UNII: 331KBJ17RK)
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)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHOCOLATE (Coffee)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65692-0504-1	4.25 g in 1 TUBE; Type 0: Not a Combination Product	02/17/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	02/17/2020	10/01/2021

Labeler - Raining Rose, Inc (083819404)

Revised: 11/2021

Document Id: cfd12699-652a-5d24-e053-2a95a90a8683

Set id: a033694b-a344-50b5-e053-2995a90ad6f8

Version: 2

Effective Time: 20211102

Raining Rose, Inc