Sunscreen Lotion Broad Spectrum Broad Spectrum SPF 30

Natural Sunscreen Broad Spectrum SPF 30 by

Drug Labeling and Warnings

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

Drug Details [pdf]

NATURAL SUNSCREEN BROAD SPECTRUM SPF 30 BABY BUM- zinc oxide lotion 
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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Sunscreen Lotion Broad Spectrum Broad Spectrum SPF 30

Active Ingredients         Purpose

Zinc Oxide 22.00%        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 or 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.

Aluminum Starch Octenylsuccinate, Persea Gratissima (Avocado Oil), Beeswax, Betacarotene, Euphorbia Cerifera (Candelilla) Wax, Caprylic/Capric Triglyceride, Daucus Carota Sativa (Carrot) Root Extract, Cucumis Sativus (Cucumber) Fruit Extract, Glyceryl Isostearate, Vitis Vinifera (Grape) Seed Oil, Camellia Sinensis Leaf Extract, Simmondsia Chinensis (Jojoba) Oil, Polyhydroxystearic Acid, Rose Hip Seed Oil, Butyrospermum Parkii (Shea) Butter, Silica, Glycine Soya (Soybean) Oil, Tocopherol, Vanillin.

Premium Natural Sunscreen Lotion

baby Bum

Broad Spectrum SPF 30

Water Resistant (80 Minutes)

3.0 FL OZ/88 ML

NATURAL SUNSCREEN BROAD SPECTRUM SPF 30  BABY BUM
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69039-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	22 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
AVOCADO OIL (UNII: 6VNO72PFC1)
YELLOW WAX (UNII: 2ZA36H0S2V)
BETA CAROTENE (UNII: 01YAE03M7J)
CANDELILLA WAX (UNII: WL0328HX19)
CAPRYLIC/CAPRIC ACID (UNII: DI775RT244)
CARROT (UNII: L56Z1JK48B)
CUCUMBER (UNII: YY7C30VXJT)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
GRAPE SEED OIL (UNII: 930MLC8XGG)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
JOJOBA OIL (UNII: 724GKU717M)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SHEA BUTTER (UNII: K49155WL9Y)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SOYBEAN OIL (UNII: 241ATL177A)
TOCOPHEROL (UNII: R0ZB2556P8)
VANILLA (UNII: Q74T35078H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69039-101-01	88 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/26/2014	08/31/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	06/26/2014	08/31/2018

Labeler - Sun Bum LLC (028642574)

Registrant - Sun Bum LLC (028642574)

Establishment
Name	Address	ID/FEI	Business Operations
Baxter Laboratories		740537709	manufacture(69039-101)

Revised: 2/2020

Document Id: 9f7f724a-94f2-26d4-e053-2995a90a0297

34390-5

Set id: da562b41-975d-4244-a994-4aec29389239

Version: 2

Effective Time: 20200226

 

Sun Bum LLC