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Drug Details [pdf]

PREMIUM NATURAL SUNSCREEN LOITION BABY BUM- zinc oxide cream
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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Active Ingredient: Purpose

Zinc Oxide 22.00% .............. Sunscreen

Uses

Helps preven sunburn
If used as directed with other sun protection measures (see Directions), decreasess 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 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

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. Spenidng 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 - 2 pm.
Wear long-sleeve shirts, pants, hats, and sunglasses
Children under 6 months: Ask a doctor

Inactive Ingredients:

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

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Baby Bum 30

Broad Spectrum SPF 30

Water Resistant (80 Minutes)

3 FL OZ / 88 mL

Box

Lotion

PREMIUM NATURAL SUNSCREEN LOITION BABY BUM
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69039-104
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
YELLOW WAX (UNII: 2ZA36H0S2V)
.BETA.-CAROTENE (UNII: 01YAE03M7J)
SHEANUT OIL (UNII: O88E196QRF)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CUCUMBER (UNII: YY7C30VXJT)
CARROT (UNII: L56Z1JK48B)
CANDELILLA WAX (UNII: WL0328HX19)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
SOYBEAN (UNII: L7HT8F1ZOD)
AVOCADO OIL (UNII: 6VNO72PFC1)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
JOJOBA OIL (UNII: 724GKU717M)
TOCOPHEROL (UNII: R0ZB2556P8)
GRAPE SEED OIL (UNII: 930MLC8XGG)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 69039-104-02	1 in 1 PACKAGE	04/27/2015	08/31/2018
1	NDC: 69039-104-01	88 mL in 1 TUBE; Type 0: Not a Combination Product

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

Labeler - Sun Bum LLC (028642574)

Registrant - Sun Bum LLC (028642574)

Name	Address	ID/FEI	Business Operations
Establishment
Baxter Laboratories		740537709	manufacture(69039-104)

Revised: 2/2020

Document Id: 9f8056c7-16e9-6342-e053-2a95a90ae5cd

Set id: ebde69d1-7cce-4a03-a732-21ce87639033

Version: 5

Effective Time: 20200226

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Drug Labeling and Warnings

Drug Details [pdf]

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