PREMIUM NATURAL SUNSCREEN BROAD SPECTRUM SPF 30 BABY BUM- zinc oxide stick

Premium Natural Sunscreen Broad Spectrum SPF 30 by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients         Purpose

Zinc Oxide 20%   ........... Sunscreen

PURPOSE

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

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

INDICATIONS & USAGE

Stop used 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 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 INGREDIENT

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

PRINCIPAL DISPLAY PANEL

Premium Natural Sunscreen Stick

Baby Bum 30

Broad Spectrum SPF 30

Water Resistant (80minutes

.45 OZ / 13 G

INGREDIENTS AND APPEARANCE

PREMIUM NATURAL SUNSCREEN BROAD SPECTRUM SPF 30  BABY BUM
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70157-007
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: 70157-007-02	1 in 1 CARTON	04/27/2015
1	NDC: 70157-007-01	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

Labeler - Baxter Laberatories (740537709)

Registrant - Baxter Laberatories (740537709)

Establishment
Name	Address	ID/FEI	Business Operations
Baxter Laberatories		740537709	manufacture(70157-007)