RADIABLOCK (OXYBENZONE, OCTINOXATE) LIPSTICK [MEDLINE INDUSTRIES, INC.]

RADIABLOCK (OXYBENZONE, OCTINOXATE) LIPSTICK [MEDLINE INDUSTRIES, INC.]
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NDC	53329-094-83
Set ID	a82dbb9c-a101-4045-89f6-5def8096546e
Category	HUMAN OTC DRUG LABEL
Packager	Medline Industries, Inc.
Generic Name
Product Class
Product Number
Application Number	PART352

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Active ingredient

Oxybenzone 3%

Padimate O 7%
Purpose

Sunscreen

Sunscreen
Uses

Helps prevent sunburn
Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

For external use only.

Do not use on damaged or broken skin.

Stop use and ask a doctor if rash occurs.

When using this product keep out of eyes. Rinse with water to remove.

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

Apply liberally 15 minutes before sun exposure

Use a water resistant sunscreen if swimming or sweating

Reaaply at least every 2 hours

Children under 6 months: Ask a doctor
Principal Display Panel

SPF 15 Lip Balm

NDC 53329-094-83

Carrington

RadiaBlock

Sunscreen SPF 15

Net Wt: .015 oz/4.2g

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INGREDIENTS AND APPEARANCE

RADIABLOCK
oxybenzone, octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53329-094
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	30 mg in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
COCOA BUTTER (UNII: 512OYT1CRR)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
CORN OIL (UNII: 8470G57WFM)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MINERAL OIL (UNII: T5L8T28FGP)
PARAFFIN (UNII: I9O0E3H2ZE)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYL GALLATE (UNII: 8D4SNN7V92)
JOJOBA OIL (UNII: 724GKU717M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53329-094-83	4.2 g in 1 TUBE; Type 0: Not a Combination Product	03/01/2013

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/01/2013

Labeler - Medline Industries, Inc. (025460908)

Name	Address	ID/FEI	Business Operations
Establishment
Bentley Laboratories, LLC		068351753	manufacture(53329-094)

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