SUN BUM SPF 50 PREMIUM MOISTURIZING SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene lotion

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

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Active ingredient:
Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 10%, Sunscreen
Available from:
Sun Bum LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
- Helps prevent sunburn - higher SPF gives more sunburn protection - 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:
69039-230-01

SUN BUM SPF 50 PREMIUM MOISTURIZING SUNSCREEN- avobenzone, homosalate,

octisalate, octocrylene lotion

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 SPF 50 Premium Moisturizing Sunscreen

Drug Facts

Active Ingredients

Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 10%

Purpose

Sunscreen

Uses

Helps prevent sunburn

higher SPF gives more sunburn protection

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 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 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-sleeved shirts, pants, hats, and sunglasses.

Children under 6 months: Ask a doctor.

Other Information

protect this product from excessive heat and directed sun

Inactive ingredients

water, butyloctyl salicylate, hydrated silica, VP/hexadecene copolymer, styrene/acrylates copolymer,

dimethicone, polyester-8, caprylyl methicone, ethylhexyl stearate, trideceth-6, glyceryl stearate, PEG-

100 stearate, fragrance, sodium polyacrylate, behenyl alcohol, dimethyl capramide, ethylhexylglycerin,

trimethylsloxysilicate, xanthan gum, polyaminopropyl biguanide, tocopheryl acetate, BHT, disodium

EDTA, methylisothiazolinone

Questions?

call 1-877-978-6286

Package Labeling:

SUN BUM SPF 50 PREMIUM MOISTURIZING SUNSCREEN

avobenzone, homosalate, octisalate, octocrylene lotion

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 9 0 39 -230

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 mL

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

HOMOSALATE

10 0 mg in 1 mL

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

OCTISALATE

50 mg in 1 mL

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

OCTOCRYLENE

10 0 mg in 1 mL

Sun Bum LLC

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

BUTYLO CTYL SALICYLATE (UNII: 2EH13UN8 D3)

HYDRATED SILICA (UNII: Y6 O7T4G8 P9 )

VINYLPYRRO LIDO NE/HEXADECENE CO PO LYMER (UNII: KFR5QEN0 N9 )

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

PO LYESTER-8 ( 14 0 0 MW, CYANO DIPHENYLPRO PENO YL CAPPED) (UNII: T9 29 6 U138 P)

CAPRYLYL TRISILO XANE (UNII: Q9 5M2P1KJL)

ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)

TRIDECETH-6 (UNII: 3T5PCR2H0 C)

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

PEG-10 0 STEARATE (UNII: YD0 1N19 9 9 R)

DO CO SANO L (UNII: 9 G1OE216 XY)

DIMETHYL CAPRAMIDE (UNII: O29 Y6 X2JEZ)

ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

XANTHAN GUM (UNII: TTV12P4NEE)

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

BUTYLATED HYDRO XYTO LUENE (UNII: 1P9 D0 Z171K)

EDETATE DISO DIUM ANHYDRO US (UNII: 8 NLQ36 F6 MM)

METHYLISO THIAZO LINO NE (UNII: 229 D0 E1QFA)

Product Characteristics

Color

white

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 9 0 39 -230 -0 1 9 47 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 5/10 /20 12

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 5/10 /20 12

Labeler -

Sun Bum LLC (028642574)

Revised: 5/2019

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