SUN BUM MINERAL SPF50 SUNSCREEN FACE- zinc oxide stick

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)
Available from:
SUN BUM, LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Authorization status:
OTC monograph not final
Authorization number:
69039-257-00

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

pa rt352

0 5/15/20 19

Labeler -

SUN BUM, LLC (028642574)

Revised: 5/2019

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