SUN BUM MINERAL SPF30 CONTINUOUS SUNSCREEN- zinc oxide spray

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)

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 MINERAL SPF30 CONTINUOUS SUNSCREEN- ZINC OXIDE 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._
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SUN BUM MINERAL SPF30 CONTINUOUS SUNSCREEN SPRAY
_DRUG FACTS_
_ACTIVE INGREDIENT_
Zinc oxide 14%
_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
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 or 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_
• shake well before use • 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 into 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 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
INAC