SUN BUM SPF 30 SUNSCREEN LIP BALM PINEAPPLE- avobenzone, octinoxate, homosalate, octisalate stick

Sun Bum SPF 30 Sunscreen Lip Balm Pineapple by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

Active Ingredients

Avobenzone 2.00%,  Octinoxate 7.50%

Homosalate 15.00%  Octisalate 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, 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, Camellia 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 Arvense Extract, Ethylhexyl Palmitate, Fragrance, Ginkgo Biloba Leaf Extract, Hydrated Silica, Isostearyl Linoleate, Macrocystis Pyrifera (Kelp) Extract, Mineral Oil, Ozokerite, Panax Ginseng Root Extract, PEG-80, Polysorbate 80, Propylene Glycol, Punica Granatum (Pomegranate) Extract, Rosmarinus Officinalis (Rosemary) Extract, Saccharin, Salix Alba (Willow) Bark Extract, Salvia Officinalis (Sage) Extract, Theobroma 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 SPF 30 SUNSCREEN LIP BALM PINEAPPLE 
avobenzone, octinoxate, homosalate, octisalate stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69039-276
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	20 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	150 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S) (UNII: R9TPS68K19)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETYL ALCOHOL (UNII: 936JST6JCN)
GRAPEFRUIT (UNII: O82C39RR8C)
LEMON PEEL (UNII: 72O054U628)
CUCUMBER (UNII: YY7C30VXJT)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIISOBUTYL ADIPATE (UNII: 8OPY05ZY7S)
DIMETHICONE (UNII: 92RU3N3Y1O)
EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
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 3500 (UNII: FVS1AZD90Y)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)
ROSEMARY (UNII: IJ67X351P9)
SACCHARIN (UNII: FST467XS7D)
SALIX ALBA BARK (UNII: 205MXS71H7)
CLARY SAGE (UNII: U3HSK5JC0Q)
COCOA BUTTER (UNII: 512OYT1CRR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69039-276-00	4.25 g in 1 TUBE; Type 0: Not a Combination Product	12/28/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/28/2017

Labeler - Sun Bum, LLC (028642574)