ADVANCED FORMULA LIP MOISTURIZER SUNSCREEN 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 Moisturizer Sunscreen SPF 25

​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:

CartonLabel

ADVANCED FORMULA LIP MOISTURIZER SUNSCREEN SPF 25 
avobenzone,octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69144-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.03 g  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69144-001-071 in 1 CARTON09/08/201501/15/2020
17 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/08/201501/15/2020
Labeler - Anthony Brands LLC (080923952)

Revised: 11/2020
Document Id: b3ef2bb2-c335-2d57-e053-2995a90a5fe0
Set id: b8eddaa8-3bd8-44d8-b210-9f00273cfccc
Version: 4
Effective Time: 20201112
 
Anthony Brands LLC