SPF15- avobenzone, homosalate, octocrylene, octisalate lipstick

SPF15 by

Drug Labeling and Warnings

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 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:

INGREDIENTS AND APPEARANCE

SPF15 
avobenzone, homosalate, octocrylene, octisalate lipstick

Product Information
Product Type	HUMAN OTC DRUG	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: 70412-316-15	4.5 g in 1 TUBE; Type 0: Not a Combination Product	06/01/2018
2	NDC: 70412-316-20	5.67 g in 1 TUBE; Type 0: Not a Combination Product	06/01/2018
3	NDC: 70412-316-07	2 g in 1 TUBE; Type 0: Not a Combination Product	12/01/2018

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)