SUN ,BUG HANDSFREE 01- avobenzone,homosalate,octocrylene,octisalate cream

Sun ,Bug Handsfree by

Drug Labeling and Warnings

Sun ,Bug Handsfree by is a Otc medication manufactured, distributed, or labeled by Cosmuses Cosmetics (Ningbo) Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Avobenzone 3%

Homosalate 10%

Octocrylene 10%

Octisalate 5%

Purpose

Sunscreen

Uses

• Helps prevent sunburn
• If used as directed with other sun protection measures (see Directions), decreased the risk of skin cancer and early skin aging caused by then sun.

Warnings

For external use only

DO NOT USE

Do not use on damaged or broken skin.

WHEN USING

When using this product keep out of eyes. Rinse with water to remove.

STOP USE

Stop use and ask a doctor if rash occurs.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If prduct is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally 15minutes before sun exposure
• reapply:
• after 80 minutes of swimming or sweating
• immediate after towel drying
• at least every 2 hours
• Sun Protection Measures

Spending time increases your risk of skin cancer and early skin aging. To decreases this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

• limit time in the sun, especially from 10a.m.- 2p.m.
• wear long-sleeve shirts, pants, hats and sunglasses
• children under 6 months:Ask a doctor

Inactive ingredients

Aqua, Glycerin, Isopropyl Myristate, Cetearyl Alcohol, Glyceryl Stearate, Ceteth-25, Beeswax, Citronella oil, Lemongrass oil, peppermint oil, Phenoxyethanol, Fragrance, Methylparaben, Propylparaben, Disodium EDTA, BHT

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUN ,BUG HANDSFREE  01
avobenzone,homosalate,octocrylene,octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82953-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PEPPERMINT OIL (UNII: AV092KU4JH)
CITRONELLA OIL (UNII: QYO8Q067D0)
EAST INDIAN LEMONGRASS OIL (UNII: UP0M8M3VZW)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETETH-25 (UNII: 5KLY4IOG20)
METHYLPARABEN (UNII: A2I8C7HI9T)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82953-010-01	10 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/26/2022
2	NDC: 82953-010-02	15 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/26/2022
3	NDC: 82953-010-03	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/26/2022
4	NDC: 82953-010-04	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/26/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/26/2022

Labeler - Cosmuses Cosmetics (Ningbo) Co., Ltd. (725290934)

Registrant - Cosmuses Cosmetics (Ningbo) Co., Ltd. (725290934)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmuses Cosmetics (Ningbo) Co., Ltd.		725290934	manufacture(82953-010)