SUN BUM PREMIUM SPF 15 SUNSCREEN TANNING- avobenzone, homosalate, octisalate, octocrylene oil

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

Buy It Now

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 - 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:
69039-278-00

SUN BUM PREMIUM SPF 15 SUNSCREEN TANNING- avobenzone, homosalate, octisalate,

octocrylene oil

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 Premium SPF 15 Sunscreen Tanning Oil

Drug Facts

Active Ingredients

Avobenzone 3%, Homosalate 10%,

Octisalate 5% Octocrylene 10%

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

mineral oil, aloe barbadensis leaf extract, prunus armeniaca (apricot) kernel oil, simmondsia chinensis

(jojoba) seed oil, prunus amygdalus dulcis (sweet almond) oil, helianthus annuus (sunflower) seed oil,

cocos nucifera (coconut) oil, linum usitatissimum (linseed) seed oil, persea gratissima (avocado) oil,

argania spinosa kernel oil, macadamia ternifolia seed oil, olea europaea (olive) fruit oil, passiflora

edulis seed oil, rosa canina fruit oil, camellia oleifera seed oil, theobroma cacao (cocoa) seed butter,

camellia sinensis leaf powder, sclerocarya birrea seed oil, hydrogenated vegetable oil, fragrance

Questions?

Call 1-877-978-6286

Package Labeling:

SUN BUM PREMIUM SPF 15 SUNSCREEN TANNING

avobenzone, homosalate, octisalate, octocrylene oil

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 9 0 39 -278

Sun Bum LLC

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

Inactive Ingredients

Ingredient Name

Stre ng th

MINERAL O IL (UNII: T5L8 T28 FGP)

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

APRICO T KERNEL O IL (UNII: 54JB35T0 6 A)

JO JO BA O IL (UNII: 724GKU717M)

ALMO ND O IL (UNII: 6 6 YXD4DKO9 )

SUNFLO WER O IL (UNII: 3W1JG79 5YI)

CO CO NUT O IL (UNII: Q9 L0 O73W7L)

LINSEED O IL (UNII: 8 4XB4DV0 0 W)

AVO CADO O IL (UNII: 6 VNO72PFC1)

ARGAN O IL (UNII: 4V59 G5UW9 X)

MACADAMIA O IL (UNII: 5156 10 SU8 C)

O LIVE O IL (UNII: 6 UYK2W1W1E)

PASSIFLO RA EDULIS SEED O IL (UNII: F3VOA31UHQ)

RO SA CANINA FRUIT O IL (UNII: CR730 7M3QZ)

CAMELLIA O IL (UNII: T1PE0 6 G0 VE)

CO CO A BUTTER (UNII: 512OYT1CRR)

GREEN TEA LEAF (UNII: W2ZU1RY8 B0 )

SCLERO CARYA BIRREA SEED O IL (UNII: WDO4TLS35F)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 9 0 39 -278 -0 0

250 mL in 1 BOTTLE; 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: 4/2019

Similar products

Search alerts related to this product

View documents history

Share this information