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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70412-315-20	5.67 g in 1 TUBE; Type 0: Not a Combination Product	07/07/2016	03/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Version: 4

Effective Time: 20191226

Zhejiang Ayan Biotech Co.,Ltd.