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:

Label3

SPF15
avobenzone, homosalate, octocrylene, octisalate lipstick

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	06/01/2018

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

SPF15 Lip Balm