ADVANCED FORMULA LIP BALM SPF 25- avobenzone, octinoxate cream

Advanced Formula Lip Balm SPF 25 by

Drug Labeling and Warnings

Advanced Formula Lip Balm SPF 25 by is a Otc medication manufactured, distributed, or labeled by Anthony Skin LLC, Fragrance Manufacturing, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients:

Avobenzone 3.0%
Octinoxate 7.5%

Purpose

Sunscreen

Uses:

Sun protection measures spending time in the sun increases your risk of skin cancer and early skin aging.

Directions:

Apply liberally 15 minutes before sun exposure.

Other Information:

Protect this product from excessive heat and direct sun.

Warnings:

Do not use

on damaged or broken skin when using this product. Keep out of eyes. Rinse with water to remove.

Stop use

and ask a doctor if rash occurs.

Keep out of reach of children.

For External Use Only.

Inactive Ingredients:

Petrolatum, Cera Alba (Beeswax), Butyrospermum Parkii (Shea Butter), Persea Gratissima (Avocado) Oil, Flavor (Aroma), Resveratrol, Camellia Sinensis (White Tea) Leaf Extract, Camellia Sinensis (Green Tea) Leaf Extract, Tocopheryl Acetate, Carthamus Tinctorius (Safflower) Seed Oil, Stevia Rebaudiana Leaf Extract, Titanium Dioxide (CI 77891), Limonene.

Principal Display Panel

Advanced Formula
Lip Balm SPF 25
With Resveratrol
& Stevia
Mint + White Tea

Anthony™

7 g ℮ .25 oz
 
 
DIST BY: Anthony Skin LLC
Stony Point, NY 10980
RP. MSL-BL9 5NB. UK
STE 5385, 27 UPPER
PEMBROKE ST, DUBLIN IE
 
Made in the USA
www.anthony.com

Label

INGREDIENTS AND APPEARANCE

ADVANCED FORMULA LIP BALM SPF 25 
avobenzone, octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80949-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
YELLOW WAX (UNII: 2ZA36H0S2V)
SHEA BUTTER (UNII: K49155WL9Y)
AVOCADO OIL (UNII: 6VNO72PFC1)
SAFFLOWER OIL (UNII: 65UEH262IS)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
RESVERATROL (UNII: Q369O8926L)
WHITE TEA (UNII: O0M3396E09)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
LIMONENE, (+)- (UNII: GFD7C86Q1W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80949-001-07	7 g in 1 TUBE; Type 0: Not a Combination Product	01/05/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/05/2020

Labeler - Anthony Skin LLC (117392467)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing, Inc.		793406000	MANUFACTURE(80949-001)