KEY WEST TAN SPF15- octinoxate, octisalate, oxybenzone, avobenzone, octocrylene lotion

United States - English - NLM (National Library of Medicine)

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Active ingredient:
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W), OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y), AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX), OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)
Available from:
QS Key West Aloe, LLC
INN (International Name):
OCTINOXATE
Composition:
OCTINOXATE 50 mg in 1 g
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Sunscreen - 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 ​Stop use and ask a doctor if ​ - Rash or irritation develops and lasts
Authorization status:
OTC monograph final
Authorization number:
65008-004-08

KEY WEST TAN SPF15- octinoxate, octisalate, oxybenzone, avobenzone, octocrylene lotion

QS Key West Aloe, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Sunsorb

SPF30

Active Ingredients

Octinoxate 5.0% (w/w)

Octisalate 3.0% (w/w)

Oxybenzone 2.0% (w/w)

Avobenzone 2.0% (w/w)

Octocrylene 1.5% (w/w)

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 or irritation develops and lasts

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

- After 80 minutes of swimming or sweating

- Immediately after towel drying

- At least every 2 hrs

Sun Protection Measures . Spending time in the sun increases your risk of skin cancer and early

skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF 15 or higher and

other skin protection measures including:

- limit time in the sun, especially from 10 a.m. - 2 p.m.

- wear long-sleeve shirts, pants, hats, and sunglasses

Children under 6 months: Ask a doctor

Inactive Ingredients:

Water, Aloe Barbadensis Leaf Extract, Adipic Acid/Diethylene Glycol Glycerin Crosspolymer,

Polycrylene, Isopropyl Myristate, Propylene Glycol, Hydrogenated Polyisobutene, Polyethylene,

Allantoin, Sodium Ascorbic Phosphate, Tocopheryl Acetate, Retinyl Palmitate, Cetyl Alcohol,

Triethanolamine, C12-15 Alkyl Benzoate, Sorbitan Stearate, Fragrance, Acrylates/c10-30 Alkyl

Acrylate Crosspolymer, Polysorbate 20, Carbomer, Caprylyl Glycol, Disodium EDTA,

Methylisothiazolinone

Other Information

- Protect this product from excessive heat and direct sun.

Questions or Comments?

1-800-445-2563

KEY WEST TAN SPF15

octinoxate, octisalate, oxybenzone, avobenzone, octocrylene lotion

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 50 0 8 -0 0 4

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

OCTINOXATE

50 mg in 1 g

QS Key West Aloe, LLC

O CTISALATE (UNII: 4X49 Y0 59 6 W) (OCTISALATE - UNII:4X49 Y0 59 6 W)

OCTISALATE

30 mg in 1 g

O XYBENZO NE (UNII: 9 5OOS7VE0 Y) (OXYBENZONE - UNII:9 5OOS7VE0 Y)

OXYBENZONE

20 mg in 1 g

AVO BENZO NE (UNII: G6 3QQF2NOX) (AVOBENZONE - UNII:G6 3QQF2NOX)

AVOBENZONE

20 mg in 1 g

O CTO CRYLENE (UNII: 5A6 8 WGF6 WM) (OCTOCRYLENE - UNII:5A6 8 WGF6 WM)

OCTOCRYLENE

15 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

ADIPIC ACID/DIGLYCO L CRO SSPO LYMER ( 2 0 0 0 0 MPA.S) (UNII: R9 TPS6 8 K19 )

PO LYESTER-8 ( 14 0 0 MW, CYANO DIPHENYLPRO PENO YL CAPPED) (UNII: T9 29 6 U138 P)

ISO PRO PYL MYRISTATE (UNII: 0 RE8 K4LNJS)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

HYDRO GENATED PO LYBUTENE ( 13 0 0 MW) (UNII: 7D1YQ9 Y5EZ)

HIGH DENSITY PO LYETHYLENE (UNII: UG0 0 KM4WR7)

ALLANTO IN (UNII: 344S277G0 Z)

SO DIUM ASCO RBYL PHO SPHATE (UNII: 8 36 SJG51DR)

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

VITAMIN A PALMITATE (UNII: 1D1K0 N0 VVC)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

TRO LAMINE (UNII: 9 O3K9 3S3TK)

ALKYL ( C12 -15) BENZO ATE (UNII: A9 EJ3J6 1HQ)

SO RBITAN MO NO STEARATE (UNII: NVZ4I0 H58 X)

CARBO MER INTERPO LYMER TYPE A ( 550 0 0 CPS) (UNII: 59 TL3WG5CO)

PO LYSO RBATE 2 0 (UNII: 7T1F30 V5YH)

CAPRYLYL GLYCO L (UNII: 0 0 YIU5438 U)

EDETATE DISO DIUM ANHYDRO US (UNII: 8 NLQ36 F6 MM)

METHYLISO THIAZO LINO NE (UNII: 229 D0 E1QFA)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 50 0 8 -0 0 4-0 8

227 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

0 2/26 /20 15

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt352

0 7/0 7/20 0 4

Labeler -

QS Key West Aloe, LLC (969600555)

Revised: 3/2016

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