OTC Medication Information: Sunscreen Lip Balm

SUNSCREEN LIP BALM- octinoxate and padimate o stick
NingBo Huize Commodity Co.,Ltd.

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.

Active Ingredient

Octylmethoxycinnamate 4%,
2-ethylhexyl 4-(dimethylamino)benzoate 7.5%

Purpose

Sunscreen

Use

Helps prevent sunburn.
If used as directed with other sun protection
measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

WARNINGS

For external use only.
When using this products
■apply to the lips
■Lips are the softest part of your face and the most exposed to Constant exposure to sun ,air,dust,pollution,bacteria and a variety of food items,makes the lips dry
■They need a little extra care and protection to retain their softness
■These lip balm ingredients are harmless to your tender skin which makes lip balm an absolutely safe product to use.
Stop use and ask a doctor if rash occurs

keep out of reach of children

Keep out of reach of children. If product is swallowed, get
medical help or contact a Poison Control Center right away.

Directions

Directions
■Apply liberally 15 minutes before sun exposure
■after 80 minutes of swimming or sweating, immediately after towel drying.
■To decrease the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher
■at least every 2 hours.
■ Spending time in the sun increases your risk of skin cancer and early skin aging

Inactive ingredients

Synthetic wax,Hydrogenated polyisobutene,liquid paraffin ,flavor,Vitamin E

lebel

SUNSCREEN LIP BALM padimate o,octinoxate stick

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71011-002 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (OCTINOXATE) OCTINOXATE 4 g in 100 g PADIMATE O (PADIMATE O) PADIMATE O 7.5 g in 100 g

Inactive Ingredients Ingredient Name Strength HYDROGENATED POLYBUTENE (1300 MW) PARAFFIN VITAMIN A MYRISTATE 1.ALPHA.,24S-DIHYDROXYVITAMIN D2 SYNTHETIC WAX (1200 MW)

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:71011-002-01 10 g in 1 PACKAGE None 2 NDC:71011-002-02 13 g in 1 PACKAGE None 3 NDC:71011-002-03 14 g in 1 PACKAGE None 4 NDC:71011-002-04 15 g in 1 PACKAGE None 5 NDC:71011-002-05 16 g in 1 PACKAGE None 6 NDC:71011-002-06 19 g in 1 PACKAGE None 7 NDC:71011-002-07 20 g in 1 PACKAGE None 8 NDC:71011-002-08 25 g in 1 PACKAGE None 9 NDC:71011-002-09 30 g in 1 PACKAGE None 10 NDC:71011-002-11 3 g in 1 PACKAGE None 11 NDC:71011-002-12 4 g in 1 PACKAGE None 12 NDC:71011-002-13 5 g in 1 PACKAGE None 13 NDC:71011-002-14 6 g in 1 PACKAGE None 14 NDC:71011-002-15 7 g in 1 PACKAGE None 15 NDC:71011-002-16 8 g in 1 PACKAGE None 16 NDC:71011-002-17 9 g in 1 PACKAGE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 10/08/2016

Labeler — NingBo Huize Commodity Co.,Ltd. (544434795)

Establishment
Name	Address	ID/FEI	Operations
NingBo Huize Commodity Co.,Ltd.		544434795	manufacture (71011-002)

Revised: 01/2018 NingBo Huize Commodity Co.,Ltd.