SUN BUM MINERAL SPF30 TINTED SUNSCREEN FACE- titanium dioxide, zinc oxide cream

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 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 TINTED SUNSCREEN FACE- TITANIUM DIOXIDE, ZINC
OXIDE CREAM
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 TINTED SUNSCREEN FACE LOTION
_DRUG FACTS_
_ACTIVE INGREDIENT_
Titanium dioxide 3.2%
Zinc oxide 1.8%
_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.
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, cucumis sativus (cucumber) fruit
extract, butyrospermum parkii (shea
butter), oenothera biennis (evening primrose) oil, linum usitatissimum
(linseed) seed oil, rosa canina
fruit oil, plankton extract, glycerin, mica, iron oxides, propylene
carbonate, synthetic wax, hydrogen
dimethicone, isopropyl