PREMIUM NATURAL SUNSCREEN BROAD SPECTRUM SPF 30 BABY BUM- zinc oxide stick 
Baxter Laberatories

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 Premium Natural Sunscreen Stick  Broad Spectrum SPF 30

Active Ingredients         Purpose

Zinc Oxide 20%   ........... Sunscreen

Uses

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Stop used and ask a doctor if rash occurs

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

Directions

Inactive Ingredients

Butyrospermum Parkii (shea) Butter, Caprylic/Capric Triglyceride, Cera Alba, Copernicia Cerifer(Carnauba) Wax, Euphorbia Cerifera (Candelilla) Wax, Blyceryl Isostearate, Polyhydroxystearic Acid, Parfum, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Ricinus Communis (Castor) Seed Oil, Tocopherol

Premium Natural Sunscreen Stick

Baby Bum 30

Broad Spectrum SPF 30

Water Resistant (80minutes

.45 OZ / 13 G

Stick

carton

PREMIUM NATURAL SUNSCREEN BROAD SPECTRUM SPF 30  BABY BUM
zinc oxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70157-007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION20 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SHEANUT OIL (UNII: O88E196QRF)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
WHITE WAX (UNII: 7G1J5DA97F)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CANDELILLA WAX (UNII: WL0328HX19)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
ALMOND OIL (UNII: 66YXD4DKO9)  
CASTOR OIL (UNII: D5340Y2I9G)  
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70157-007-021 in 1 CARTON04/27/2015
1NDC:70157-007-0113 g in 1 CYLINDER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/27/2015
Labeler - Baxter Laberatories (740537709)
Registrant - Baxter Laberatories (740537709)
Establishment
NameAddressID/FEIBusiness Operations
Baxter Laberatories740537709manufacture(70157-007)

Revised: 1/2017
Document Id: 9840b7f2-5152-4d38-a01d-f261e3352991
Set id: 3a87d88e-3cb7-499c-9d04-d172f7f6bde7
Version: 4
Effective Time: 20170105
 
Baxter Laberatories