SUN XSPF 30 BROAD SPECTRUM SUNSCREEN LIP BALM- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lipstick

Sun XSPF 30 Broad Spectrum Sunscreen Lip Balm by

Drug Labeling and Warnings

Sun XSPF 30 Broad Spectrum Sunscreen Lip Balm by is a Otc medication manufactured, distributed, or labeled by CoreTex Products, INC, Raining Rose. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Do not use on damaged or broken skin.

STOP USE

Stop use and ask a doctor if

• rash occurs

WHEN USING

When using this product

• keep out of eyes. Rinse 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 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:

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

Inactive Ingredients

Beeswax, castor oil, cocoa butter, coconut oil, shea utter

Other Information

Protect this productfrom excessive heat and direct sun.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUN XSPF 30 BROAD SPECTRUM SUNSCREEN LIP BALM 
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65753-105
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.5 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	6 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	7.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
COCONUT OIL (UNII: Q9L0O73W7L)
WHITE WAX (UNII: 7G1J5DA97F)
SHEA BUTTER (UNII: K49155WL9Y)
COCOA BUTTER (UNII: 512OYT1CRR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65753-105-36	24 in 1 CONTAINER	01/01/2017
1		4.44 mL in 1 APPLICATOR; Type 0: Not a Combination Product
2	NDC: 65753-105-23	50 in 1 CONTAINER	01/01/2017
2		4.44 mL in 1 APPLICATOR; Type 0: Not a Combination Product
3	NDC: 65753-105-38	72 in 1 CONTAINER	01/01/2017
3		4.44 mL in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/01/2017

Labeler - CoreTex Products, INC (061944620)

Establishment
Name	Address	ID/FEI	Business Operations
CoreTex Products, INC		061944620	label(65753-105)

Establishment
Name	Address	ID/FEI	Business Operations
Raining Rose		083819404	manufacture(65753-105)