SUNSCREEN- octocrylene, ethylhexyl methoxycinnamate, benzophenone-3, butyl methoxydibenzoylmethane stick

Sunscreen by

Drug Labeling and Warnings

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

Octocrylene 8%
Ethylhexyl Methoxycinnamate 7.5%
Benzophenone-3 3%
Butyl Methoxydibenzoylmethane 1.5%

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

Beeswax, Butyrospermum Parkii (Shea Butter), Caprylic/Capric Triglycerides, Copernicia Cerifera (Carnauba) Wax, Ethylhexyl Palmitate, Flavor, Microcrystalline Wax, Ozokerite Wax, Petrolatum, Pentaerythrityl Tetraisostearate, Polybutene, Punica Granatum Extract, Vitis Vinifera
(Grape) Seed Extract, Tocopheryl Acetate, Triticum Vulgare (Wheat) Germ Oil.

Other Information

Protect from excessive heat and direct sun.

Package Labeling:

INGREDIENTS AND APPEARANCE

SUNSCREEN 
octocrylene, ethylhexyl methoxycinnamate, benzophenone-3, butyl methoxydibenzoylmethane stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70412-210
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	80 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	30 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	15 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX (UNII: 2ZA36H0S2V)
SHEA BUTTER (UNII: K49155WL9Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CARNAUBA WAX (UNII: R12CBM0EIZ)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
METHYL SALICYLATE (UNII: LAV5U5022Y)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
CERESIN (UNII: Q1LS2UJO3A)
PETROLATUM (UNII: 4T6H12BN9U)
PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)
VITIS VINIFERA SEED (UNII: C34U15ICXA)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WHEAT GERM OIL (UNII: 14C97E680P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70412-210-15	15 g in 1 TUBE; Type 0: Not a Combination Product	07/07/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/07/2016

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