SUN BUM TINTED SPF15 SUNSCREEN SUNSET COVE- avobenzone, octinoxate, octisalate stick

Sun Bum Tinted SPF15 Sunscreen Sunset Cove by

Drug Labeling and Warnings

Sun Bum Tinted SPF15 Sunscreen Sunset Cove 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 1.9%, Octinoxate 7.1%, Octisalate 4.9%

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 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 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

Other information

protect this product from excessive heat and direct sun

Inactive ingredients

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

Questions?

call 1 (877) 978-6286

Package Labeling:

INGREDIENTS AND APPEARANCE

SUN BUM TINTED SPF15 SUNSCREEN SUNSET COVE 
avobenzone, octinoxate, octisalate stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69039-264
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	19 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	71 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	49 mg  in 1 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69039-264-00	4.25 g in 1 CARTRIDGE; Type 0: Not a Combination Product	04/15/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/15/2018

Labeler - Sun Bum LLC (028642574)