SUN BUM TINTED LIP BALM RAISIN HELL- homosalate, octisalate, octocrylene, zinc oxide stick

Sun Bum Tinted Lip Balm Raisin Hell by

Drug Labeling and Warnings

Sun Bum Tinted Lip Balm Raisin Hell 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

Homosalate 10%, Octisalate 5%

Octocrylene 3%, Zinc Oxide 2.85%

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 swallowed, get medical help or contact a Poison Control Center immediately.

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
• use a water resistant sunscreen if swimming or sweating
• children under 6 months of age: ask a doctor.
• 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 a.m. - 2 p.m.
• wear long-sleeved shirts, pants, hats, and sunglasses.

Other Information

protect this product from excessive heat and direct sun

Inactive Ingredients

beeswax, cocos nucifera (coconut) oil, ricinus communis (castor) seed oil, butyrospermum parkii (shea) butter, caprylic/capric triglyceride, olea europaea (olive) fruit oil, theobroma grandiflorum seed butter, copernicia cerifera (carnauba) wax, euphorbia cerifera (candelilla) wax, flavor, helianthus annuus (sunflower) seed oil, polyhydroxystearic acid, limnanthes alba (meadowfoam) seed oil, aloe barbadensis leaf extract, simmondsia chinensis (jojoba) seed oil, carthamus tinctorius (safflower) seed oil, tocopherol, jojoba esters, octyldodecyl oleate, stevia rebaudiana extract, indigofera tinctoria leaf extract, glycine soja (soybean) oil, silica, carmine, mica, iron oxide, tin oxide, titanium dioxide

Questions?

call 1 (877) 978-6286

Package Labeling:

INGREDIENTS AND APPEARANCE

SUN BUM TINTED LIP BALM RAISIN HELL 
homosalate, octisalate, octocrylene, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69039-265
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	30 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	28.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX (UNII: 2ZA36H0S2V)
COCONUT OIL (UNII: Q9L0O73W7L)
CASTOR OIL (UNII: D5340Y2I9G)
SHEA BUTTER (UNII: K49155WL9Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
OLIVE OIL (UNII: 6UYK2W1W1E)
THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CANDELILLA WAX (UNII: WL0328HX19)
METHYL SALICYLATE (UNII: LAV5U5022Y)
SUNFLOWER OIL (UNII: 3W1JG795YI)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
JOJOBA OIL (UNII: 724GKU717M)
SAFFLOWER OIL (UNII: 65UEH262IS)
TOCOPHEROL (UNII: R0ZB2556P8)
OCTYLDODECYL OLEATE (UNII: MCA43PK7MH)
INDIGOFERA TINCTORIA LEAF (UNII: 2K7DF8HZDM)
SOYBEAN OIL (UNII: 241ATL177A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
STANNIC OXIDE (UNII: KM7N50LOS6)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	red	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69039-265-00	4.25 g in 1 TUBE; Type 0: Not a Combination Product	04/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/01/2019

Labeler - Sun Bum, LLC (028642574)