Label: SPF 30 LIP BALM- titanium dioxide stick
- NDC Code(s): 53634-129-01
- Packager: Malin and Goetz Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated June 14, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions
- Apply Liberally and evenly 15 minutes before sun exposure
- Children under 6 months of age: Ask a doctor
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 value of 15 or higher and other sun protection measures including:
- Limit time in the sun especially from 10 am- 2pm
- Wear long-sleeved shirts, pants, hats & sunglasses
- Reapply after 40 minutes of swimming or sweating
- Immediately after towel drying
- At least every 2 hours
- OTHER SAFETY INFORMATION
- OTHER SAFETY INFORMATION
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INACTIVE INGREDIENT
Inactive Ingredients
Hydrogenated Polyisobutene, Ethylhexyl Palmitate, Hydrogenated Styrene/Isoprene Copolymer, Hydrogenated Polydecene, Flavor, Cinnamal, Cinnamyl Alcohol, Coumarin, d-Limonene, Eugenol, Methyl 2 Octynoate, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Urolic Acid, Tocopherol, Stearic Acid, Aluminum Hydroxide.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SPF 30 LIP BALM
titanium dioxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53634-129 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 3.3 g in 100 mL Inactive Ingredients Ingredient Name Strength CINNAMYL ALCOHOL (UNII: SS8YOP444F) EUGENOL (UNII: 3T8H1794QW) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) LIMONENE, (+)- (UNII: GFD7C86Q1W) METHYL HEPTINE CARBONATE (UNII: 0TTP6YT2T3) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) COUMARIN (UNII: A4VZ22K1WT) TOCOPHEROL (UNII: R0ZB2556P8) URSOLIC ACID (UNII: P3M2575F3F) CINNAMALDEHYDE (UNII: SR60A3XG0F) STEARIC ACID (UNII: 4ELV7Z65AP) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) ETHYLHEXYL PALMITATE (UNII: 2865993309) HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53634-129-01 10 mL in 1 TUBE; Type 0: Not a Combination Product 05/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 05/01/2023 Labeler - Malin and Goetz Inc (138615930)
