SUNSCREEN 01- avobenzone,homosalate,octocrylene,octisalate spray

SUNSCREEN by

Drug Labeling and Warnings

SUNSCREEN 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 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, Glyceryl Stearate, Ceteth-25, Phenoxyethanol, Fragrance, Methylparaben, Propylparaben, Disodium EDTA, BHT, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, PEG-100 stearate.

Other information

Protect this product from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUNSCREEN  01
avobenzone,homosalate,octocrylene,octisalate spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82953-018
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
PEG-100 STEARATE (UNII: YD01N1999R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
LAURETH-7 (UNII: Z95S6G8201)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CETETH-25 (UNII: 5KLY4IOG20)
METHYLPARABEN (UNII: A2I8C7HI9T)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
POLYACRYLAMIDE (CROSSLINKED; 0.01-0.2 MOLE PERCENT BISACRYLAMIDE) (UNII: RHA9LWJ494)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
FRAGRANCE 13576 (UNII: 5EM498GW35)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82953-018-02	20 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/30/2024
2	NDC: 82953-018-05	8 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/30/2024
3	NDC: 82953-018-06	18 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/30/2024
4	NDC: 82953-018-07	5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/30/2024
5	NDC: 82953-018-03	25 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/30/2024
6	NDC: 82953-018-04	15 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/30/2024
7	NDC: 82953-018-01	10 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/30/2024
8	NDC: 82953-018-08	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/30/2024
9	NDC: 82953-018-09	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/30/2024
10	NDC: 82953-018-10	90 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/30/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/30/2024

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(82953-018)