Label: RADIABLOCK- oxybenzone and octinoxate lipstick
- NDC Code(s): 53329-094-83
- Packager: Medline Industries, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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
Padimate O 7%Close
Helps prevent sunburnClose
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.Close
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 doctorClose
- Principal Display Panel
SPF 15 Lip Balm
Sunscreen SPF 15
Net Wt: .015 oz/4.2gClose
- INGREDIENTS AND APPEARANCE
oxybenzone, octinoxate lipstick
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:53329-094 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYBENZONE (OXYBENZONE) OXYBENZONE 30 mg in 1 g OCTINOXATE (OCTINOXATE) OCTINOXATE 75 mg in 1 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF BUTYLATED HYDROXYANISOLE CITRIC ACID MONOHYDRATE CARNAUBA WAX MINERAL OIL PARAFFIN PETROLATUM PROPYL GALLATE JOJOBA OIL COCOA BUTTER .ALPHA.-TOCOPHEROL CORN OIL VITAMIN A PALMITATE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53329-094-83 4.2 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/01/2013 Labeler - Medline Industries, Inc. (025460908)