PREMIUM NATURAL SUNSCREEN LOITION BABY BUM- zinc oxide cream

Premium Natural Sunscreen Loition by

Drug Labeling and Warnings

Premium Natural Sunscreen Loition by is a Otc medication manufactured, distributed, or labeled by Baxter Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient:                 Purpose

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

PURPOSE

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

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

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs

WARNINGS

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

DOSAGE & ADMINISTRATION

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 INGREDIENT

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

PRINCIPAL DISPLAY PANEL

Premium Natural Sunscreen Lotion 

Baby Bum 30

Broad Spectrum SPF 30

Water Resistant (80 Minutes)

 3 FL OZ / 88 mL

INGREDIENTS AND APPEARANCE

PREMIUM NATURAL SUNSCREEN LOITION  BABY BUM
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70157-006
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 mL

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70157-006-02	1 in 1 PACKAGE	04/27/2015
1	NDC: 70157-006-01	88 mL in 1 TUBE; 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

Labeler - Baxter Laboratories (740537709)

Registrant - Baxter Laboratories (740537709)

Establishment
Name	Address	ID/FEI	Business Operations
Baxter Laboratories		740537709	manufacture(70157-006)