Label: SUN SHADES LIP BALM COCONUT SMOOTHIE- avobenzone, octinoxate, oxybenzone stick
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Contains inactivated NDC Code(s)
NDC Code(s): 54473-259-01 - Packager: Melaleuca 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 May 10, 2017
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warnings
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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Directions
■ apply liberally 15 minutes before sun exposure
■ reapply at least every 2 hours ■ use a water-resistant sunscreen if swimming or sweating ■ 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 a.m.-2 p.m.■ wear long-sleeve shirts, pants, hats, and sunglasses
- Other information
- Other Information
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SUN SHADES LIP BALM COCONUT SMOOTHIE
avobenzone, octinoxate, oxybenzone stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54473-259 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.1175 g in 4.25 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.282 g in 4.25 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.141 g in 4.25 g Inactive Ingredients Ingredient Name Strength ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C) CERESIN (UNII: Q1LS2UJO3A) CETYL ESTERS WAX (UNII: D072FFP9GU) COCOA BUTTER (UNII: 512OYT1CRR) ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE) (UNII: L5F16ZG4ZU) JOJOBA OIL (UNII: 724GKU717M) PETROLATUM (UNII: 4T6H12BN9U) YELLOW WAX (UNII: 2ZA36H0S2V) CANDELILLA WAX (UNII: WL0328HX19) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54473-259-01 4.25 g in 1 APPLICATOR; Type 0: Not a Combination Product 02/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 05/14/2015 Labeler - Melaleuca Inc. (139760102) Registrant - Melaleuca Inc. (139760102) Establishment Name Address ID/FEI Business Operations Melaleuca Inc. 079711683 manufacture(54473-259)
