ADVANCED FORMULA LIP MOISTURIZER SUNSCREEN SPF 25- avobenzone,octinoxate cream

Advanced Formula Lip Moisturizer Sunscreen SPF 25 by

Drug Labeling and Warnings

Advanced Formula Lip Moisturizer Sunscreen SPF 25 by is a Otc medication manufactured, distributed, or labeled by Anthony Brands LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

​Drug Facts

​Active ingredients

Avobenzone 3.0%

Octinoxate 7.5%

​Purpose

Sunscreen

Use​

• Helps protect against sunburn.

​Warnings

​Skin Cancer/Skin Aging Alert: ​Spending time in the sun oncreases your risk of skin cancer and early skin aging.  ​This product has been shown only to help prevent sunburn,  ​not ​skin cancer or early skin aging.

​For external use only,

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.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply generously 15 minutes before sun exposure.
• Children under 6 years of age:  Ask a doctor
• Reapply at least every 2 years.
• Use a water resistant sunscreen if swimming or sweating.

​Other Information

• Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

PETROLATUM, BEESWAX, SHEA (BUTYROSPERMUM PARKII) BUTTER, AVOCADO (PERSEA GRATISSIMA) OIL, FLAVOR, RESVERATROL, WHITE TEA (CAMELLIA SINENSIS) LEAF EXTRACT, GREEN TEA (CAMELLIA SINENSIS) LEAF EXTRACT, TOCOPHEROL ACETATE, SAFFLOWER (CARTHAMUS TINCTORIUS) SEED OIL, STEVIA (STEVIA REBAUDIANA) LEAF EXTRACT, TITANIUM DIOXIDE

Product Labeling:

INGREDIENTS AND APPEARANCE

ADVANCED FORMULA LIP MOISTURIZER SUNSCREEN SPF 25 
avobenzone,octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69144-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.03 g  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 g  in 1 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69144-001-07	1 in 1 CARTON	09/08/2015
1		7 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/08/2015

Labeler - Anthony Brands LLC (080923952)