SUN BUM SUNSCREEN LIP BALM BROAD SPECTRUM SPF 30 WATERMELON- avobenzone, homosalate, octocrylene, octisalate stick

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

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Active ingredient:
Avobenzone 3%, Homosalate 10%, Octocrylene 8%, Octyl Salicylate 5%, Sunscreen
Available from:
Sun Bum, LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
- 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
Authorization status:
OTC monograph not final
Authorization number:
69039-601-01

SUN BUM SUNSCREEN LIP BALM BROAD SPECTRUM SPF 30 WATERMELON-

avobenzone, homosalate, octocrylene, octisalate stick

Sun Bum, 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.

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Sun Bum Sunscreen Lip Balm Broad Spectrum SPF 30 Watermelon

Drug Facts

Active Ingredients

Avobenzone 3%, Homosalate 10%

Octocrylene 8%, Octyl Salicylate 5%

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

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

aloe barbadensis leaf extract, argania spinosa kernel oil, bisabolol, camellia sinensis leaf extract,

caprylic/capric triglyceride, cetyl alcohol, cucumis sativus (cucumber) fruit extract, diisobutyl adipate,

equisetum arvense extract, ethyl hexyl palmitate, fragrance, hydrogenated ethylhexyl olivate,

hydrogenated olive oil unsaponifiables, isostearyl linoleate, mineral oil, ozokerite, polysorbate 80,

propylene glycol, punica granatum extract, rosmarinus officinalis extract, saccharin, salix alba (willow)

bark extract, salvia officinalis (sage) extract, silica, theobroma cacao seed butter, tocopheryl acetate,

tocopheryl linoleate/oleate, water

Questions?

Call 1 (877) 978-6286

Package Labeling:

SUN BUM SUNSCREEN LIP BALM BROAD SPECTRUM SPF 30 WATERMELON

avobenzone, homosalate, octocrylene, octisalate stick

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 9 0 39 -6 0 1

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

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

AVOBENZONE

30 mg in 1 g

HO MO SALATE (UNII: V0 6 SV4M9 5S) (HOMOSALATE - UNII:V0 6 SV4M9 5S)

HOMOSALATE

10 0 mg in 1 g

Sun Bum, LLC

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

OCTOCRYLENE

8 0 mg in 1 g

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

OCTISALATE

50 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

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

ARGAN O IL (UNII: 4V59 G5UW9 X)

LEVO MENO L (UNII: 24WE0 3BX2T)

GREEN TEA LEAF (UNII: W2ZU1RY8 B0 )

MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9 H2L21V7U)

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

CUCUMBER (UNII: YY7C30 VXJT)

DIISO BUTYL ADIPATE (UNII: 8 OPY0 5ZY7S)

EQ UISETUM ARVENSE BRANCH (UNII: 1L0 VKZ18 5E)

ETHYLHEXYL PALMITATE (UNII: 28 6 59 9 330 9 )

HYDRO GENATED O LIVE O IL UNSAPO NIFIABLES (UNII: B8 MIX9 7W9 5)

ISO STEARYL LINO LEATE (UNII: 4778 M3HR0 N)

MINERAL O IL (UNII: T5L8 T28 FGP)

CERESIN (UNII: Q1LS2UJO3A)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

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

PUNICA GRANATUM RO O T BARK (UNII: CLV24I3T1D)

RO SEMARY (UNII: IJ6 7X351P9 )

SACCHARIN (UNII: FST46 7XS7D)

SALIX ALBA BARK (UNII: 20 5MXS71H7)

SAGE (UNII: 0 6 5C5D0 77J)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

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

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 9 0 39 -6 0 1-0 1

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

0 1/0 1/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 1/0 1/20 19

Labeler -

Sun Bum, LLC (028642574)

Revised: 5/2019

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