SPF15 SUNSCREEN- avobenzone, homosalate, octocrylene, octisalate stick

SPF15 Sunscreen by

Drug Labeling and Warnings

SPF15 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 8%
Octocrylene 5.5%
Avobenzone 2%
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 (Sunscreen)

Mineral Oil, Beeswax, Ozokerite, Cera Microcristallina, Cocos Nucifera (Coconut) Oil, Ethylhexyl Palmitate, Ethylhexyl Palmitate, Polyisobutene,
Polyethylene, Tridecyl Trimellitate, Butyrospermum Parkii (Shea Butter), BHT, Tocopheryl Acetate,Flavor. May Contain: Blue 1 Lake (CI 42090),
Yellow 5 Lake(CI 19140), Yellow 6 Lake (CI 15985), Titanium Dioxide (CI 77891), Red 6 Lake (CI 15850), Red 7 Lake (CI 15850), Red 27 Lake (CI 45410), Red 28 Lake (CI 45410), Red 30 Lake (CI 73360), Iron Oxides (CI 77492, CI 77491, CI 77499).

Other Information

• Protect from excessive heat and direct sun.

Package Labeling:

INGREDIENTS AND APPEARANCE

SPF15 SUNSCREEN 
avobenzone, homosalate, octocrylene, octisalate stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70412-212
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)
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)
METHYL SALICYLATE (UNII: LAV5U5022Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70412-212-02	2 g in 1 TUBE; Type 0: Not a Combination Product	10/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/01/2018

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