Label: SUNSCREEN LIP BALM- padimate o,octinoxate stick
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Contains inactivated NDC Code(s)
NDC Code(s): 71011-002-01, 71011-002-02, 71011-002-03, 71011-002-04, view more71011-002-05, 71011-002-06, 71011-002-07, 71011-002-08, 71011-002-09, 71011-002-11, 71011-002-12, 71011-002-13, 71011-002-14, 71011-002-15, 71011-002-16, 71011-002-17 - Packager: NingBo Huize Commodity Co.,Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated January 6, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Use
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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 -
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
- lebel
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INGREDIENTS AND APPEARANCE
SUNSCREEN LIP BALM
padimate o,octinoxate stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71011-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 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 Business Operations NingBo Huize Commodity Co.,Ltd. 544434795 manufacture(71011-002)
