SPEARMINT SPF 15 LIP- avobenzone, octinoxate, octisalate, octocrylene stick BEESWAX SPF 15 LIP- avobenzone, octinoxate, octisalate, octocrylene stick POMEGRANATE SPF 15 LIP- avobenzone, octinoxate, octisalate, octocrylene stick TROPICAL SPF 15 LIP- avobenzone, octinoxate, octisalate, octocrylene stick VANILLA SPF 15 LIP- avobenzone, octinoxate, octisalate, octocrylene stick

Vanilla SPF 15 Lip by

Drug Labeling and Warnings

Vanilla SPF 15 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 FACTS Broad Spectrum SPF 15 Sunscreen Spearmint Lip Balm, Beeswax Lip Balm, Pomegranate Lip Balm, Tropical Lip Balm, Vanilla Lip Balm Drug Facts

Active Ingredients:
Avobenzone 2.0%
Octinoxate 6.5%
Octsalate 5.0%
Octocrylene 1.5%

Purpose

Sunscreen

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.

Uses

Helps prevent sunburn

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.

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 sun protection measures including limit time in the sun, especially from 10a.m. - 2p.m.  wear long sleeved shirts, pants, hats, and sunglasses.

Inactive Ingredients

Sunflower oil*, beeswax, extra virgin olive oil*, hemp seed oil*, rosemary extract, vitamin E, aloe vera
*Certified Organic

Other Information

Protect this product from excessive heat and direct sun.

Product Label Spearmint Lip Balm Beeswax Lip Balm Pomegranate Lip Balm Tropical Lip Balm Vanilla Lip Balm

Dist. by: Raining Rose, Inc. Cedar Rapids IA 52403    L000000

PEEL HERE FOR DRUG FACTS
Broad Spectrum SPF Sunscreen

NetWt. .15 oz

Spearmint Lip Balm
Beeswax Lip Balm
Pomegranate Lip Balm
Tropical Lip Balm
Vanilla Lip Balm

INGREDIENTS AND APPEARANCE

SPEARMINT SPF 15 LIP  
avobenzone, octinoxate, octisalate, octocrylene stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65692-0301
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
SUNFLOWER OIL (UNII: 3W1JG795YI)
YELLOW WAX (UNII: 2ZA36H0S2V)
OLIVE OIL (UNII: 6UYK2W1W1E)
SPEARMINT (UNII: J7I2T6IV1N)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
ROSEMARY (UNII: IJ67X351P9)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65692-0301-1	4.25 g in 1 PACKAGE; Type 0: Not a Combination Product	12/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	12/01/2012

BEESWAX SPF 15 LIP 
avobenzone, octinoxate, octisalate, octocrylene stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65692-0302
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.09 g  in 4.25 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.28 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	0.06 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: 65692-0302-1	4.25 g in 1 PACKAGE; Type 0: Not a Combination Product	12/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	12/01/2012

POMEGRANATE SPF 15 LIP 
avobenzone, octinoxate, octisalate, octocrylene stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65692-0303
Route of Administration	TOPICAL

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65692-0303-1	4.25 g in 1 PACKAGE; Type 0: Not a Combination Product	12/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	12/01/2012

TROPICAL SPF 15 LIP 
avobenzone, octinoxate, octisalate, octocrylene stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65692-0304
Route of Administration	TOPICAL

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

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: 65692-0304-1	4.25 g in 1 PACKAGE; Type 0: Not a Combination Product	12/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	12/01/2012

VANILLA SPF 15 LIP 
avobenzone, octinoxate, octisalate, octocrylene stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65692-0305
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.09 g  in 4.25 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.28 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	0.06 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: 65692-0305-1	4.25 g in 1 PACKAGE; Type 0: Not a Combination Product	12/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	12/01/2012

Labeler - Raining Rose, Inc. (083819404)

Registrant - Raining Rose, Inc. (083819404)

Establishment
Name	Address	ID/FEI	Business Operations
Raining Rose, Inc.		083819404	manufacture(65692-0301, 65692-0305, 65692-0302, 65692-0303, 65692-0304)