BABY BUM MINERAL SPF50 SUNSCREEN- 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
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
Authorization number:
69039-271-00

BABY BUM MINERAL SPF50 SUNSCREEN- 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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Baby Bum Mineral SPF50 Sunscreen Face Stick

Drug Facts

Active ingredient

Zinc oxide 19.2%

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 right away.

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

Other information

protect this product from excessive heat and direct sun keep this outer card for complete labeling

information

Inactive ingredients

cocos nucifera (coconut) oil, persea gratissima (avocado) oil, limnanthes alba (meadowfoam) seed oil,

linum usitatissimum (linseed) seed oil, oryza sativa (rice bran) wax, euphorbia cerifera (candelilla) wax,

butyloctyl salicylate, copernicia cerifera (carnauba) wax, ozokerite, butyrospermum parkii (shea

butter), oryzanol, fragrance, theobroma cacao (cocoa) seed butter, carthamus tinctorius (safflower) seed

oil, jojoba esters, tocopherol, bisabolol

Questions?

call 1-877-978-6286

Package Labeling:

BABY BUM MINERAL SPF50 SUNSCREEN

zinc oxide stick

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 9 0 39 -271

Route of Administration

TOPICAL

Sun Bum LLC

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

CO CO NUT O IL (UNII: Q9 L0 O73W7L)

AVO CADO O IL (UNII: 6 VNO72PFC1)

MEADO WFO AM SEED O IL (UNII: 412ZHA4T4Y)

LINSEED O IL (UNII: 8 4XB4DV0 0 W)

RICE BRAN (UNII: R6 0 QEP13IC)

CANDELILLA WAX (UNII: WL0 328 HX19 )

BUTYLO CTYL SALICYLATE (UNII: 2EH13UN8 D3)

CARNAUBA WAX (UNII: R12CBM0 EIZ)

CERESIN (UNII: Q1LS2UJO3A)

SHEA BUTTER (UNII: K49 155WL9 Y)

GAMMA O RYZANO L (UNII: SST9 XCL51M)

CO CO A BUTTER (UNII: 512OYT1CRR)

SAFFLO WER O IL (UNII: 6 5UEH26 2IS)

TO CO PHERO L (UNII: R0 ZB2556 P8 )

LEVO MENO L (UNII: 24WE0 3BX2T)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 9 0 39 -271-0 0

1 in 1 CARTON

0 6 /13/20 18

1

13 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

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 6 /13/20 18

Labeler -

Sun Bum LLC (028642574)

Revised: 4/2019

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