LIP BALM SPF15 SUNSCREEN SPF30 COMBO- octocrylene, ethylhexyl methoxycinnamate, benzophenone-3, butyl methoxydibenzoylmethane
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 SPF15+Sunscreen SPF30 Combo

Drug Facts

Active Ingredients (Sunscreen)

Octocrylene 8%
Ethylhexyl Methoxycinnamate 7.5%
Benzophenone-3 3%
Butyl Methoxydibenzoylmethane 1.5%

Purpose

Sunscreen

Active Ingredients (Lip Balm)

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(Sunscreen)

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

Inactive Ingredients(Lip Balm)

Other Information

Protect from excessive heat and direct sun.

Package Labeling:

Label

LIP BALM SPF15 SUNSCREEN SPF30 COMBO
octocrylene, ethylhexyl methoxycinnamate, benzophenone-3, butyl methoxydibenzoylmethane kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70412-815

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70412-815-10	1 in 1 KIT; Type 0: Not a Combination Product	01/17/2016	03/01/2020

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 TUBE	2 g
Part 2	1 TUBE	4.5 g

Part 1 of 2

SUNSCREEN
octocrylene, ethylhexyl methoxycinnamate, benzophenone-3, butyl methoxydibenzoylmethane stick

Product Information
Item Code (Source)	NDC:70412-210
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	80 mg in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	30 mg in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	15 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)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
CERESIN (UNII: Q1LS2UJO3A)
PETROLATUM (UNII: 4T6H12BN9U)
PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)
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:70412-210-02	2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	01/17/2016

Part 2 of 2

LIP BALM SPF15
ethylhexyl methoxycinnamate, benzophenone-3 stick

Product Information
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)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
CERESIN (UNII: Q1LS2UJO3A)
PETROLATUM (UNII: 4T6H12BN9U)
PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)
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:70412-315-15	4.5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	01/17/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	01/17/2016	03/01/2020

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

Name	Address	ID/FEI	Business Operations
Establishment
Zhejiang Ayan Biotech Co.,Ltd.		544377996	manufacture(70412-815, 70412-210, 70412-315)

Revised: 12/2019

Document Id: 9a9d1ff3-e20a-f807-e053-2995a90ac18f

Set id: 049b772d-ef70-4ec0-8005-b559f0b138ec

Version: 5

Effective Time: 20191226

Zhejiang Ayan Biotech Co.,Ltd.