SUN BUM MINERAL SPF50 SUNSCREEN FACE- zinc oxide stick

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

SUN BUM, LLC

administration_route:

TOPICAL

prescription_type:

OTC DRUG

authorization_status:

OTC monograph not final

SPC

SUN BUM MINERAL SPF50 SUNSCREEN FACE- ZINC OXIDE 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 MINERAL SPF50 SUNSCREEN FACE STICK
ACTIVE INGREDIENT:
Zinc oxide 19.2%
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
KEEP OUTER CARTON FOR COMPLETE LABELING INFORMATION
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.
PACKAGE LABELING:
SUN BUM MINERAL SPF50 SUNSCREEN FACE
zinc oxide stick
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 9 0 39 -257
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8 SF37)
ZINC CATION
19 2 mg in 1 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:6 9 0 39 -257-0 0
13 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct
0 5/15/20 19
SUN BUM, LLC
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TING START DATE
MARKE TING END DATE
OTC mo no graph no t final
p