SUN BUM TINTED SPF15 SUNSCREEN SANDBAR- avobenzone, octinoxate, octisalate stick

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX), OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)

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 aging caused by the sun

Authorization status:

OTC monograph not final

Summary of Product characteristics

SUN BUM TINTED SPF15 SUNSCREEN SANDBAR- AVOBENZONE, OCTINOXATE,
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 TINTED SPF15 SUNSCREEN LIP BALM SANDBAR
_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 bar