SUN BUM MINERAL SPF 30 TINTED SUNSCREEN FACE- titanium dioxide, zinc oxide lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP), ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)

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 SPF 30 TINTED SUNSCREEN FACE- TITANIUM DIOXIDE, ZINC
OXIDE LOTION
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 SPF 30 TINTED SUNSCREEN FACE LOTION
_DRUG FACTS_
_ACTIVE INGREDIENTS_
Titanium dioxide 5.3%
Zinc oxide 2.4%
_PURPOSE_
Sunscreen
_USE_S
• 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 40 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_
cyclopentasiloxane, isopropyl myristate, polyamide-5, stearalkonium
hectorite,
dimethicone crosspolymer, polysilicone 11, oryza sativa (rice) bran
extract, rosmarinus
officinalis (rosemary) leaf extract, helianthus annuus (sunflower)
extract, tocopherol,
mica, iron oxides, propylene carbonate, synthetic wax, hydrogen
dimethicone, isopropyl
titanium triisostearate, aluminum hydroxide, silica silylate,
octyldode