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:

LIP BALM SPF15 
ethylhexyl methoxycinnamate, benzophenone-3 stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70412-315
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	30 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70412-315-20	5.67 g in 1 TUBE; Type 0: Not a Combination Product	07/07/2016	03/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/07/2016	03/01/2020

Labeler - Zhejiang Ayan Biotech Co.,Ltd. (544377996)

Revised: 12/2019

Document Id: 9a9d2393-fe7e-73e4-e053-2a95a90a149f

34390-5

Set id: b694fee3-6af2-43f3-a063-d42974b55c2e

Version: 4

Effective Time: 20191226