ADVANCED FORMULA LIP BALM SPF 25- avobenzone, octinoxate cream 
Anthony Skin LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Advanced Formula Lip Balm SPF 25

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

image-01

Label

ADVANCED FORMULA LIP BALM SPF 25 
avobenzone, octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80949-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80949-001-077 g in 1 TUBE; Type 0: Not a Combination Product01/05/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/05/2020
Labeler - Anthony Skin LLC (117392467)
Establishment
NameAddressID/FEIBusiness Operations
Fragrance Manufacturing, Inc.793406000MANUFACTURE(80949-001)

Revised: 4/2023
Document Id: 74d7bc30-db15-4cfc-8918-40897d54da70
Set id: 74d7bc30-db15-4cfc-8918-40897d54da70
Version: 1
Effective Time: 20230403
 
Anthony Skin LLC