AMOREPACIFIC RESORT COLLECTION SUN PROTECTION MIST- homosalate, octocrylene, octisalate, and avobenzone spray

Amorepacific Resort Collection Sun Protection Mist by

Drug Labeling and Warnings

Amorepacific Resort Collection Sun Protection Mist by is a Otc medication manufactured, distributed, or labeled by AMOREPACIFIC CORPORATION. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENTS

AVOBENZONE 3%
HOMOSALATE 14%
OCTISALATE 4.5%
OCTOCRYLENE 9%

PURPOSE

Sunscreen

USES

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

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.
• Reapply at least every 2 hours.
• Use a water-resistant sunscreen if swimming or sweating.
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease 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 10 a.m. - 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses.
• Children under 6 months of age: Ask a doctor.

INACTIVE INGREDIENTS

ALCOHOL, C12-15 ALKYL BENZOATE, CYCLOPENTASILOXANE, CYCLOHEXASILOXANE, PHYLLOSTACHIS BAMBUSOIDES JUICE, TRICHOLOMA MATSUTAKE EXTRACT, PRUNUS MUME FRUIT EXTRACT, PORTULACA OLERACEA EXTRACT, ACRYLATES/OCTYLACRYLAMIDE COPOLYMER, BUTYLENE GLYCOL, FRAGRANCE

OTHER INFORMATION

Protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL - 200 ml Bottle Carton

RESORT COLLECTION
Sun Protection Mist
Broad Spectrum
SPF 30
SUNSCREEN

AMOREPACIFIC

6.76 FL. OZ./200 ml e

INGREDIENTS AND APPEARANCE

AMOREPACIFIC RESORT COLLECTION SUN PROTECTION MIST 
homosalate, octocrylene, octisalate, and avobenzone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43419-522
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	28000 mg  in 200 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	18000 mg  in 200 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	9000 mg  in 200 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	6000 mg  in 200 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
PHYLLOSTACHYS RETICULATA RESIN (UNII: KX390ME4SP)
PRUNUS MUME FRUIT (UNII: 639190I8CU)
PURSLANE (UNII: M6S840WXG5)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43419-522-31	1 in 1 CARTON	02/13/2015	08/01/2018
1		200 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 43419-522-38	1 in 1 CARTON	08/01/2018	08/31/2019
2		80 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 43419-522-02	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2018	10/22/2020
4	NDC: 43419-522-37	1 in 1 CARTON	08/01/2018	10/22/2020
4		200 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/13/2015	10/22/2020

Labeler - AMOREPACIFIC CORPORATION (631035289)

Establishment
Name	Address	ID/FEI	Business Operations
AMOREPACIFIC CORPORATION		694894112	manufacture(43419-522)