LIP BALM SPF15 by Zhejiang Ayan Biotech Co.,Ltd. Lip Balm SPF 15

LIP BALM SPF15 by

Drug Labeling and Warnings

LIP BALM SPF15 by is a Otc medication manufactured, distributed, or labeled by Zhejiang Ayan Biotech Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LIP BALM SPF15- ethylhexyl methoxycinnamate, benzophenone-3 stick 
Zhejiang Ayan Biotech 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.

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Lip Balm SPF 15

Drug Facts

Active Ingredients

Ethylhexyl Methoxycinnamate 7.5%
Benzophenone-3 3%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn.

Warnings

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

Directions

Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Children under 6 months: Ask a doctor.

Inactive Ingredients

Beeswax, Butyrospermum Parkii (Shea Butter), Caprylic/Capric Triglycerides, Copernicia Cerifera (Carnauba) Wax, Ethylhexyl Palmitate, Flavor, Microcrystalline Wax, Ozokerite Wax, Petrolatum, Pentaerythrityl Tetraisostearate, Polybutene, Punica Granatum Extract, Vitis Vinifera
(Grape) Seed Extract, Tocopheryl Acetate, Triticum Vulgare (Wheat) Germ Oil.

Other Information

Protect from excessive heat and direct sun.

Package Labeling:

Label

LIP BALM SPF15 
ethylhexyl methoxycinnamate, benzophenone-3 stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70412-315
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE30 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
YELLOW WAX (UNII: 2ZA36H0S2V)  
SHEA BUTTER (UNII: K49155WL9Y)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
CERESIN (UNII: Q1LS2UJO3A)  
PETROLATUM (UNII: 4T6H12BN9U)  
PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)  
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)  
VITIS VINIFERA SEED (UNII: C34U15ICXA)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WHEAT GERM OIL (UNII: 14C97E680P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70412-315-205.67 g in 1 TUBE; Type 0: Not a Combination Product07/07/201603/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/07/201603/01/2020
Labeler - Zhejiang Ayan Biotech Co.,Ltd. (544377996)

Revised: 12/2019