SPF 15 LIP AND SPF 30 SUNSCREEN- avobenzone, homosalate, octocrylene, octisalate 
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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SPF 15 Lip Balm and SPF 30Sunscreen Stick

Drug Facts

Active Ingredients

Homosalate 2%
Avobenzone 8%
Octocrylene 5.5%
Octisalate 2%

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

Mineral Oil, Beeswax(Cera Alba), Cera Microcristallina, Ozokerite, Polyisobutene, Cocos Nucifera (Coconut) Oil, Ethylhexyl Palmitate, Polyethylene, Tridecyl Trimellitate, Butyrospermum Parkii (Shea Butter), BHT, Tocopheryl Acetate, Fragrance.

Other Information

• Protect from excessive heat and direct sun.

Questions?

Call AP Specialties

Drug Facts

Active Ingredients

Homosalate 2%
Avobenzone 8%
Octocrylene 5.5%
Octisalate 2%

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

Mineral Oil, Cera Microcristallina, Polyisobutene, Cocos Nucifera (Coconut) Oil, Ethylhexyl Palmitate, Polyethylene, Hydroxystearic Acid, Butyrospermum Parkii (Shea Butter), Tridecyl Trimellitate, Ozokerite, Synthetic Wax, Dextrin Palmitate, BHT, Tocopheryl Acetate, Fragrance.

Other Information

• Protect from excessive heat and direct sun.

Questions?

Call AP Specialties

Package Labeling:

Label2

SPF 15 LIP AND SPF 30 SUNSCREEN 
avobenzone, homosalate, octocrylene, octisalate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70412-816
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70412-816-101 in 1 KIT06/01/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 4.5 g
Part 21 TUBE 2 g
Part 1 of 2
SPF15 
avobenzone, homosalate, octocrylene, octisalate lipstick
Product Information
Item Code (Source)NDC:70412-316
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE80 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE55 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL (UNII: T5L8T28FGP)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CERESIN (UNII: Q1LS2UJO3A)  
COCONUT OIL (UNII: Q9L0O73W7L)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
SHEA BUTTER (UNII: K49155WL9Y)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70412-316-154.5 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/01/2018
Part 2 of 2
SPF30 SUNSCREEN 
avobenzone, homosalate, octocrylene, octisalate stick
Product Information
Item Code (Source)NDC:70412-211
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL (UNII: T5L8T28FGP)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CERESIN (UNII: Q1LS2UJO3A)  
COCONUT OIL (UNII: Q9L0O73W7L)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
SHEA BUTTER (UNII: K49155WL9Y)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70412-211-152 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/01/2018
Labeler - Zhejiang Ayan Biotech Co.,Ltd. (544377996)

Revised: 5/2018
Document Id: 6cf6a310-472d-1fe6-e053-2991aa0a60fd
Set id: 52f03bbe-76a3-43fb-b64f-e3e81f9e0558
Version: 1
Effective Time: 20180524
 
Zhejiang Ayan Biotech Co.,Ltd.