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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4 g in 100 g
PADIMATE O (UNII: Z11006CMUZ) (PADIMATE O - UNII:Z11006CMUZ)	PADIMATE O	7.5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
PARAFFIN (UNII: I9O0E3H2ZE)
VITAMIN A MYRISTATE (UNII: 7H32T49054)
1.ALPHA.,24S-DIHYDROXYVITAMIN D2 (UNII: 2900I92Z36)
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71011-002-01	10 g in 1 PACKAGE; Type 0: Not a Combination Product	10/20/2016
2	NDC:71011-002-02	13 g in 1 PACKAGE; Type 0: Not a Combination Product	10/20/2016
3	NDC:71011-002-03	14 g in 1 PACKAGE; Type 0: Not a Combination Product	10/20/2016
4	NDC:71011-002-04	15 g in 1 PACKAGE; Type 0: Not a Combination Product	10/20/2016
5	NDC:71011-002-05	16 g in 1 PACKAGE; Type 0: Not a Combination Product	10/20/2016
6	NDC:71011-002-06	19 g in 1 PACKAGE; Type 0: Not a Combination Product	10/20/2016
7	NDC:71011-002-07	20 g in 1 PACKAGE; Type 0: Not a Combination Product	10/20/2016
8	NDC:71011-002-08	25 g in 1 PACKAGE; Type 0: Not a Combination Product	10/20/2016
9	NDC:71011-002-09	30 g in 1 PACKAGE; Type 0: Not a Combination Product	10/20/2016
10	NDC:71011-002-11	3 g in 1 PACKAGE; Type 0: Not a Combination Product	10/20/2016
11	NDC:71011-002-12	4 g in 1 PACKAGE; Type 0: Not a Combination Product	10/20/2016
12	NDC:71011-002-13	5 g in 1 PACKAGE; Type 0: Not a Combination Product	10/20/2016
13	NDC:71011-002-14	6 g in 1 PACKAGE; Type 0: Not a Combination Product	10/20/2016
14	NDC:71011-002-15	7 g in 1 PACKAGE; Type 0: Not a Combination Product	10/20/2016
15	NDC:71011-002-16	8 g in 1 PACKAGE; Type 0: Not a Combination Product	10/20/2016
16	NDC:71011-002-17	9 g in 1 PACKAGE; Type 0: Not a Combination Product	10/20/2016

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

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

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

sunscreen lip balm