SUN BUM TINTED SUNSCREEN FACE UVA/UVB BROAD SPECTRUM SPF 30- 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 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 TINTED SUNSCREEN FACE UVA/UVB BROAD SPECTRUM SPF 30-
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 TINTED SUNSCREEN FACE LOTION UVA/UVB BROAD SPECTRUM SPF 30
_DRUG FACTS_
_ACTIVE INGREDIENT_
Titanium dioxide 5.3%
Zinc oxide 2.4%
_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
right away.
_DIRECTIONS_
shake well before use
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 PROTECTIONS MEASURES- Spending time in the sun increases your risk
of skin
cancer and early skin aging. To decrease this risk, regurlarly 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, rosemarinus
officinalis (rosemary) leaf extract, helianthus annus (sunflower)
extract, tocopherol,
mica, iron oxides, propylene carbonate, synthetic wax, hydrogen
dimethicone, isopropyl
titanium triisostearate, aluminum hydroxide, silica silyl