Premium Natural Sunscreen Stick - Baby Bum 30

Premium Natural Sunscreen by

Drug Labeling and Warnings

Premium Natural Sunscreen by is a Otc medication manufactured, distributed, or labeled by Sun Bum LLC, Baxter Laberatories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PREMIUM NATURAL SUNSCREEN BABY BUM 30- 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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Premium Natural Sunscreen Stick - Baby Bum 30

Active Ingredients         Purpose

Zinc Oxide 20%   ........... 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

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

• Apply liberally 15 minutes before sun exposure
• Reapply: After 80 minutes of swimming or sweating
• Immediately after towel drying
• At least every2 hours
• 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 of 15 or higher and other sun protection measures, including:
• Limit time in the sun, especially form 10 am - 2 pm.
• Wear long-sleeve shirts, pants, hats, and sunglasses
• Children under 6 months: Ask a doctor

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

PREMIUM NATURAL SUNSCREEN  BABY BUM 30
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69039-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	20 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69039-103-02	1 in 1 BOX	04/27/2015	08/31/2018
1	NDC: 69039-103-01	13 g in 1 CYLINDER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/27/2015	08/31/2018

Labeler - Sun Bum LLC (028642574)

Registrant - Sun Bum LLC (028642574)

Establishment
Name	Address	ID/FEI	Business Operations
Baxter Laberatories		740537709	manufacture(69039-103)

Revised: 2/2020

Document Id: 9f802a8c-fb1e-3cdc-e053-2a95a90adce1

34390-5

Set id: 3459ac9a-8384-45ba-9390-d0c79002c380

Version: 7

Effective Time: 20200226

 

Sun Bum LLC