SUN BUM SUNSCREEN LIP BALM BROAD SPECTRUM SPF 30 POMEGRANATE- avobenzone, homosalate, octinoxate, octisalate stick

Sun Bum Sunscreen Lip Balm Broad Spectrum SPF 30 by

Drug Labeling and Warnings

Sun Bum Sunscreen Lip Balm Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by Sun Bum LLC, Filltech USA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 2.00%

Homosalate 15.00%

Octinoxate 7.50%

Octissalate 5.00%

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.
• 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:
• After 80 minutes of swimming or sweating.
• Immediately after towel drying.
• At least every 2 hours

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 of 15 or higher and other sun protection measures.

Sun Proection Measures

including:

• Limit time in the sun, especially from 10 am - 2 pm.
• Wear long-sleeve shirts, pants, hats, and sunglasses.
• Children under 6 months: Ask a doctor.

Inactive Ingredients

Adipic Acid / Diglycol Crosspolymer, Aloe Barbadensis Leaf Extract, Ascorbic Acid, BHT, Calendula Officinalis Flower Extract, Cameilia Sinensis Leaf Extract, Caprylic / Capric Triglyceride, Cetyl Alcohol, Citrus Grandis (Grapefruit) Fruit Extract, Citrus Limon (Lemon) Peel Extract, Cucumis Sativus (Cucumber) Fruit Extract, Cyclohexasiloxane, Cyclopentasiloxane, Diisobutyl Adipate, Dimethicone, Equisetum Extract, Hydrated Silica, Isostearyl Linoleate, Macrocystis Pyrifera (kelp) Extract, mineral Oil, Oxokarite, Panax Ginseng Root Extract, PEG-8, Polysorbate 80, Propylene Glycol, Punica Granatum (Pomegranate) Extract, Rosmarinus Officinalis (Rosemary) Extract, Saccharin, Salix Alba (Willow) Bark Extract, Salvia Officnialis (Sage) Extract, Thoabroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Water.

Other information

• Protect this product from excessive heat and direct sun.

Questions or Comments?

Call + 1 (877) 978-6286

Package Labeling

INGREDIENTS AND APPEARANCE

SUN BUM SUNSCREEN LIP BALM BROAD SPECTRUM SPF 30   POMEGRANATE
avobenzone, homosalate, octinoxate, octisalate stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69039-200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	15 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ADIPIC ACID (UNII: 76A0JE0FKJ)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CETYL ALCOHOL (UNII: 936JST6JCN)
GRAPEFRUIT (UNII: O82C39RR8C)
LEMON PEEL (UNII: 72O054U628)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E)
GINKGO (UNII: 19FUJ2C58T)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
ISOSTEARYL LINOLEATE (UNII: 4778M3HR0N)
MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)
MINERAL OIL (UNII: T5L8T28FGP)
CERESIN (UNII: Q1LS2UJO3A)
ASIAN GINSENG (UNII: CUQ3A77YXI)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POMEGRANATE (UNII: 56687D1Z4D)
SACCHARIN (UNII: FST467XS7D)
WILLOW BARK (UNII: S883J9JDYX)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69039-200-01	1 in 1 CARTON	05/12/2016
1		4.25 g in 1 TUBE; 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	05/12/2016

Labeler - Sun Bum LLC (028642574)

Establishment
Name	Address	ID/FEI	Business Operations
Filltech USA, LLC		926433855	manufacture(69039-200)