SPF 15 LIP AND SPF 30 SUNSCREEN- avobenzone, homosalate, octocrylene, octisalate kit

SPF 15 Lip and SPF 30 Sunscreen by

Drug Labeling and Warnings

SPF 15 Lip and SPF 30 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Zhejiang Ayan Biotech Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

SPF 15 LIP AND SPF 30 SUNSCREEN 
avobenzone, homosalate, octocrylene, octisalate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70412-816

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70412-816-10	1 in 1 KIT	06/01/2018

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

Part 1 of 2

SPF15 
avobenzone, homosalate, octocrylene, octisalate lipstick

Product Information
Item Code (Source)	NDC: 70412-316
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	20 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	80 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	55 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70412-316-15	4.5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/01/2018

Part 2 of 2

SPF30 SUNSCREEN 
avobenzone, homosalate, octocrylene, octisalate stick

Product Information
Item Code (Source)	NDC: 70412-211
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70412-211-15	2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/01/2018

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