SUN BUM SPF 30 PREMIUM MOISTURIZING SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene spray

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

Buy It Now

Active ingredient:
Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 3.75%, 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:
69039-254-01

SUN BUM SPF 30 PREMIUM MOISTURIZING SUNSCREEN- avobenzone, homosalate,

octisalate, octocrylene spray

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.

----------

Sun Bum SPF 30 Premium Moisturizing Sunscreen

Drug Facts

Active Ingredients

Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 3.75%

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.

Flammable: do not use near heat, flame, or while smoking

Do not use

on damaged or broken skin

When using this product

keep out of eyes. Rinse with water to remove.

use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be

harmful of fatal.

do not puncture or incinerate. Contents under pressure.

Do not store at temperatures above 120°F.

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

hold container 4 to 6 inches from the skin to apply

spray liberally and spread evenly by hand 15 minutes before sun exposure

do not spray directly info face. Spray on hands then apply to face.

do not apply in windy conditions

use in well-ventilated area. reapply: after 80 minutes of swimming or sweating.

immediately after towel drying

at least every 2 hours.

children under 6 months: 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 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 directed sun

Inactive ingredients

alcohol denat. (67%), acrylates/octylacrylamide copolymer, C12-15 alkyl benzoate, dicaprylyl

carbonate, PPG-5-ceteth-20, fragrance, tocopherol

Questions?

Call 1-877-978-6286

Package Labeling:

SUN BUM SPF 30 PREMIUM MOISTURIZING SUNSCREEN

avobenzone, homosalate, octisalate, octocrylene spray

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 9 0 39 -254

Route of Administration

TOPICAL

Sun Bum LLC

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

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

OCTISALATE

50 mg in 1 g

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

OCTOCRYLENE

37.5 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

ALKYL ( C12 -15) BENZO ATE (UNII: A9 EJ3J6 1HQ)

DICAPRYLYL CARBO NATE (UNII: 6 0 9 A3V1SUA)

PPG-5-CETETH-2 0 (UNII: 4AAN25P8 P4)

TO CO PHERO L (UNII: R0 ZB2556 P8 )

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 9 0 39 -254-0 1

50 g in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 1/28 /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 1/28 /20 19

Labeler -

Sun Bum LLC (028642574)

Revised: 5/2019

Similar products

Search alerts related to this product

View documents history

Share this information