SUN BUM KIDS FACE SPF 50- avobenzone, homosalate, octisalate, octocrylene stick

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX), HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S), OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W), OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)

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

Summary of Product characteristics

SUN BUM KIDS FACE SPF 50- AVOBENZONE, HOMOSALATE, OCTISALATE,
OCTOCRYLENE 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 KIDS FACE STICK SPF 50
_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 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_
octyldodecanol, caprylic/capric triglyceride, butyloctyl salicylate,
dibutyl ethylhexanoyl
glutamide, dibutyl lauroyl glutamide, trimethylentanediol/ adipic
acid/glycerin
crosspolymer, tocopheryl acetate, fragrance, pongamol
_QUESTIONS?_
1-877-978-6286
PACKAGE LABELING:
SUN BUM KIDS FACE SPF 50
avobenzone, homosalate, octisalate, octocrylene stick
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SO