SPF30 SUNSCREEN AND SPF15- avobenzone, homosalate, octocrylene, octisalate kit

SPF30 Sunscreen and SPF15 by

Drug Labeling and Warnings

SPF30 Sunscreen and 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]

Drug Facts

Active Ingredients

Avobenzone 3%, Homosalate 10%,
Octocrylene10%, Octisalate 5%

Purpose

Sunscreen

Uses

Helps prevent sunburn

WARNINGS:

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer or early skin aging. This product has been shown only to prevent sunburn NOT skin cancer or early skin aging. This product is NOT water resistant or sweat resistant.

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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

Non-Water Resistant Product
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

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
Limit time in the sun, especially from 10 a.m. to 2 p.m.
Wear long sleeve shirts, pants, hats and sunglasses.

Inactive ingredients.

Water, Glycerin, Caprylic/Capric Triglyceride, Potassium Cetyl Phosphate, Cetearyl Alcohol, Dimethicone, Caprylyl Glycol, Phenoxyethanol, Glyceryl Stearate, VP/Hexadecene Copolymer, Bisabolol, Carbomer, Fragrance, Triethanolamine, Disodium EDTA

Other information

Protect this product from excessive heat and direct sun

Questions?

Call AP Specialties

Drug Facts

Active Ingredients

Avobenzone 3%,

Homostate 10%,

Octocrylene 10%,

Octisalate 5%

Purpose

Sunscreen

Uses

• Helps prevent sunburn

WARNINGS

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cnacer or early skin aging. this product has been shown only to prevent sunburn NOT skin cancer or early skin aging. this product is NOT water resistant or sweat resistant.

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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Non-Water Resistant Product
• 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
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

Limit time in the sun, especially from 10 a.m. to 2 p.m.
Wear long sleeve shirts, pants, hats and sunglasses.

Inactive Ingredients

Water, Glycerin, Caprylic/Capric Triglyceride, Potassium Cetyl Phosphate, Cetearyl Alcohol, Dimethicone, Caprylyl Glycol, Phenoxyethanol, Glyceryl Stearate, VP/Hexadecene Copolymer, Bisabolol, Carbomer, Fragrance, Triethanolamine, Disodium EDTA

Other information

Protect this product from excessive heat and direct sun

Questions?

Call toll free

Drug Facts

Active Ingredients

Avobenzone 2%
Octocrylene 8%
Octisalate 5.5%
Homosalate 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 reash occurs.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control right away.

Directions

• Apply liberally 15 minutes before sun exposure.
• Usa 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, Ozokerite, Cera Microcristallina, Polyisobutene, Cocos Nucifera (Coconut) Oil, Ethylhexyl Palmitate, Polyethylene, Tridencyl Trimellitate, Butyrospermum Parkii (Shea Butter), BHT, Tocopheryl Acetate, Fragrance.

Other Information

• Protect from excessive heat and direct sun.

Questions?

Call AP Specialties

BATCH NO:

Distributed by:

Package Labeling:

Package Labeling:

INGREDIENTS AND APPEARANCE

SPF30 SUNSCREEN AND SPF15 
avobenzone, homosalate, octocrylene, octisalate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70412-818

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70412-818-01	1 in 1 KIT	12/01/2018

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	30 mL
Part 2	1 TUBE	2 g

Part 1 of 2

SPF30 SUNSCREEN 
avobenzone, homosalate, octocrylene, ocitsalate lotion

Product Information
Item Code (Source)	NDC: 70412-231
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 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHICONE (UNII: 92RU3N3Y1O)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
LEVOMENOL (UNII: 24WE03BX2T)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
COCONUT (UNII: 3RT3536DHY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70412-231-30	30 mL in 1 BOTTLE; 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	12/01/2018

Part 2 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)
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: 70412-316-07	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	12/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/01/2018

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

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Ayan Biotech Co.,Ltd.		544377996	manufacture(70412-818, 70412-231)