Sun Bum Premium Natural Sunscreen Stick

Sunscreen Stick Broad Spectrum SPF 30 Sunscreen by

Drug Labeling and Warnings

Sunscreen Stick Broad Spectrum SPF 30 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Sun Bum LLC, Baxter Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SUNSCREEN STICK BROAD SPECTRUM SPF 30 SUNSCREEN BABY BUM- 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 Premium Natural Sunscreen Stick

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

Stop use 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.

If product is 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 and sweating.

Immediately after towel drying- At least every 2 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 from 10 am- 2pm

     Wear long-sleeve shirts, pants, hats, and sunglasses.

Children under 6 months: Ask a doctor.

Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Cera Alba, Copernicia Cerifera (Carnauba) Wax, Euphorbia Cerifera (Candelilla) Wax, Glyceryl Isosterate, Polyhydroxystearic Acid, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Ricinus Communis (Castor) Seed oil, Tocopherol, Vanilin.

Premium Natural Sunscreen Stick

Broad Spectrum SPF 30 Sunscreen

Ecran Solaire / Bioqueador Solar

Water resistant  (80 Minutes)

0.45 oz / 13 G

SUNSCREEN STICK BROAD SPECTRUM SPF 30 SUNSCREEN  BABY BUM
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69039-102
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
SHEA BUTTER (UNII: K49155WL9Y)
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)
VANILLA (UNII: Q74T35078H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69039-102-02	1 in 1 BOX	06/28/2014	08/31/2018
1	NDC: 69039-102-01	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	06/28/2014	08/31/2018

Labeler - Sun Bum LLC (028642574)

Registrant - Sun Bum LLC (028642574)

Establishment
Name	Address	ID/FEI	Business Operations
Baxter Laboratories		740537709	manufacture(69039-102)

Revised: 2/2020

Document Id: 9f7fe8e7-e23b-514e-e053-2a95a90aaec1

34390-5

Set id: 5c28adfb-366c-4b39-8e15-3447882c31fc

Version: 2

Effective Time: 20200226