VANILLA MINT LIP SPF 30 BALM- avobenzone, homosalate, octisalate, octocrylene, oxybenzone stick

Vanilla Mint Lip by

Drug Labeling and Warnings

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

Drug Details [pdf]

PEEL HERE FOR DRUG FACTSBROAD SPECTRUN SPF 30 SunscreenVanilla Mint Lip Balm - 0201

Active Ingredients:

Avobenzone 3.0%
Homosalate 7.5%
Octisalate 5.0%
Octocrylene 2.5%
Oxybenzone 6.0%

Purpose

Sunscreen

Uses

• Helps prevent sunburn

Warnings

For External Use Only 

Do not use

on damaged or broken skin

Stop use and as 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.

If swalowed, get medical help or call 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

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, s\especially from 10a.m. - 2p.m.
• wear long slessved shirts, pants, hat, and sunglasses.

Inactive Ingredients:

Sunflower oil*, beeswax, extra virgin olive oil*, flavor hemp seed oil*, rosemary extract, vitamin E, Aloe vera.

*Certified Organic

Other Information

Protect this product from excessive heart and direct sun.

Vanilla Mint Lip Balm SPF 30 product label

Dist. by: Raining Rose, Inc. Cedar Rapids, IA 52403

INGREDIENTS AND APPEARANCE

VANILLA MINT LIP  SPF 30 BALM
avobenzone, homosalate, octisalate, octocrylene, oxybenzone stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65692-0201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.12 g  in 4.25 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	0.32 g  in 4.25 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.21 g  in 4.25 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.10 g  in 4.25 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.25 g  in 4.25 g

Inactive Ingredients
Ingredient Name	Strength
SUNFLOWER OIL (UNII: 3W1JG795YI)
YELLOW WAX (UNII: 2ZA36H0S2V)
OLIVE OIL (UNII: 6UYK2W1W1E)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
ROSEMARY (UNII: IJ67X351P9)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65692-0201-1	4.25 g in 1 CONTAINER; Type 0: Not a Combination Product	12/19/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	12/19/2016

Labeler - Raining Rose, Inc. (083819404)

Registrant - Raining Rose, Inc. (083819404)

Establishment
Name	Address	ID/FEI	Business Operations
Raining Rose, Inc.		083819404	manufacture(65692-0201) , label(65692-0201) , relabel(65692-0201) , repack(65692-0201)