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

Drug Facts

Active Ingredients:

Avobenzone 3%

Octinoxate 7.5%

Purpose

Sunscreen

Uses:

Helps prevent sunburn.

Cautions:

Avoid contact with eyes. If irritation occurs and persisits, discontinue use and consult a physician.

Inactive Ingredients:

Petrolatum, Cera Alba(Beeswax), Butyrospermum Parkii (Shea Butter), Persea Gratissima (Avocado) Oil, Flavor (Aroma), Resveratrol, Camellia Oleifera (Green Tea) Leaf Extract, Tocopheryl Acetate, Carthamus Tinctorius (Safflower) Seed Oil, stevia Rebaudiana Leaf Extract, Titanium Dioxide (CI 77891), D-Limonene, Citral

With Resveratrol & Stevia

[ Allergy Tested]

[Dermatologist Tested]

Developed for men.

Borrowed by women.

Dist. By: Anthony Brands USA New York

R.P.MSL BL9 5NB.UK Made in the USA

www.anthony.com

Packaging

Lip Balm

ADVANCED FORMULA LIP BALM SPF 25
avobenzone, octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69144-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
PETROLATUM (UNII: 4T6H12BN9U)
YELLOW WAX (UNII: 2ZA36H0S2V)
SHEA BUTTER (UNII: K49155WL9Y)
AVOCADO OIL (UNII: 6VNO72PFC1)
RESVERATROL (UNII: Q369O8926L)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SAFFLOWER OIL (UNII: 65UEH262IS)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
CITRAL (UNII: T7EU0O9VPP)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69144-002-07	7 g in 1 TUBE; Type 0: Not a Combination Product	04/10/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	04/10/2018

Labeler - Anthony Brands, Llc (101150147)