LIP BALM SPF 15- avobenzone, octinoxate, octisalate, octocrylene lipstick

Lip Balm SPF 15 by

Drug Labeling and Warnings

Lip Balm SPF 15 by is a Otc medication manufactured, distributed, or labeled by Skin Script, LLC, Raining Rose, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients:

Avobenzone 2.0%

Octinoxate 6.5%

Octisalate 5.0%

Octocrylene 1.5%

PURPOSE

Purpose:

Sunscreen

INDICATIONS & USAGE

Uses

• Helps prevent sunburn

QUESTIONS

Dist. by: Skin ScriptTM Chandler, AZ 85226

WARNINGS

Warnings

• For External Use Only
• Do not use on damaged or broken skin
• Stop and ask a doctor if
  • rash occurs
• When using this product
• keep out of eyes. Rinse 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.

DOSAGE & ADMINISTRATION

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 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 INGREDIENT

Inactive Ingredients:

Sunflower Oil*, Beeswax, Olive Oil*, Flavor, Tocopherol, Hemp Seed Oil*, Rosemary Extract, Aloe Extract, Soybean Oil, Sunflower Seed Oil Glycerides, Canola Oil. *Organic

OTHER SAFETY INFORMATION

Other Information

Protect this product from excessive heat and direct sun.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LIP BALM SPF 15 
avobenzone, octinoxate, octisalate, octocrylene lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83657-600
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.0065 g  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.005 g  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.0015 g  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.002 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SUNFLOWER OIL (UNII: 3W1JG795YI)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
ROSEMARY OIL (UNII: 8LGU7VM393)
SOYBEAN OIL (UNII: 241ATL177A)
SUNFLOWER OIL MONO/DIGLYCERIDES (UNII: HS7EB0C1ZH)
CANOLA OIL (UNII: 331KBJ17RK)
TOCOPHEROL (UNII: R0ZB2556P8)
ALOE (UNII: V5VD430YW9)
OLIVE OIL (UNII: 6UYK2W1W1E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83657-600-01	4.25 g in 1 TUBE; Type 0: Not a Combination Product	09/03/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/03/2024

Labeler - Skin Script, LLC (050951910)

Establishment
Name	Address	ID/FEI	Business Operations
Raining Rose, Inc.		083819404	manufacture(83657-600)