BROAD SPECTRUM SPF 15 SUNSCREEN UNFLAVORED LIP BALM stick

Broad Spectrum SPF 15 Sunscreen Unflavored Lip Balm by

Drug Labeling and Warnings

Broad Spectrum SPF 15 Sunscreen Unflavored Lip Balm by is a Otc medication manufactured, distributed, or labeled by Raining Rose. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients:

Avobenzone 3.0%

Octinoxate 6.5%

Octisalate 5.0%

Octocrylene 1.5%

PURPOSE

Purpose

Sunscreen

WARNINGS

Warnings

For external use only.

DO NOT USE

Do not use on damaged or broken skin

ASK DOCTOR

Stop use and ask doctor if rash occurs

WHEN USING

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.

ROUTE, METHOD AND FREQUENCY OF ADMINISTRATION

Directions: Apply liberally 15 mintues 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 INGREDIENT

Inactive Ingredients: Petrolatum, Mineral Oil, Paraffin Wax, Ozokerite Wax, Coconut Oil, Tocopherol, Soybean Oil.

DOSAGE & ADMINISTRATION

Apply liberally 15 minutes before sun exposure

INDICATIONS & USAGE

Helps prevent sunburn

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BROAD SPECTRUM SPF 15 SUNSCREEN UNFLAVORED LIP BALM 
broad spectrum spf 15 sunscreen unflavored lip balm stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65692-0573
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.13 g  in 4.25 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.28 g  in 4.25 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.06 g  in 4.25 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.21 g  in 4.25 g

Inactive Ingredients
Ingredient Name	Strength
WHITE PETROLATUM (UNII: B6E5W8RQJ4)
PARAFFIN (UNII: I9O0E3H2ZE)
SOYBEAN OIL (UNII: 241ATL177A)
CERESIN (UNII: Q1LS2UJO3A)
COCONUT OIL (UNII: Q9L0O73W7L)
MINERAL OIL (UNII: T5L8T28FGP)
TOCOPHEROL (UNII: R0ZB2556P8)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65692-0573-1	4.25 g in 1 TUBE; Type 0: Not a Combination Product	12/13/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/13/2022

Labeler - Raining Rose (083819404)