Label: FRUIT OF THE EARTH CABANA BEACH CLUB LIP BALM WITH MANUKA HONEY AND ESSENTIAL OILS SPF 30- avobenzone, homosalate, octisalate, octocrylene stick
- NDC Code(s): 62217-083-58, 62217-083-59
- Packager: Fruit of the Earth, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 August 12, 2021
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
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Directions
- Apply liberally 15 minutes before sun exposure
- Reapply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours
- 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-sleeved shirts, pants, hats, and sunglasses
- Other information
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Inactive ingredients
C12-15 alkyl benzoate, paraffin, butyloctyl salicylate, synthetic wax, ozokerite, euphorbia cerifera (candelilla) wax, dimethicone, aloe barbadensis leaf extract, mineral oil, ascorbyl palmitate, honey (manuka honey), bertholletia excelsa seed oil (brazil nut), vaccinium macrocarpon (cranberry) seed oil, tocopheryl acetate, dimethicone crosspolymer-3, cetyl dimethicone, cetyl alcohol, caprylyl glycol, fragrance.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FRUIT OF THE EARTH CABANA BEACH CLUB LIP BALM WITH MANUKA HONEY AND ESSENTIAL OILS SPF 30
avobenzone, homosalate, octisalate, octocrylene stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62217-083 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 50 mg in 1 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 100 mg in 1 g Inactive Ingredients Ingredient Name Strength CRANBERRY SEED OIL (UNII: 73KDS3BW5E) BRAZIL NUT OIL (UNII: 0G89T29HO6) HONEY (UNII: Y9H1V576FH) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) PARAFFIN (UNII: I9O0E3H2ZE) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) CANDELILLA WAX (UNII: WL0328HX19) CERESIN (UNII: Q1LS2UJO3A) CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CETYL ALCOHOL (UNII: 936JST6JCN) MINERAL OIL (UNII: T5L8T28FGP) ASCORBYL PALMITATE (UNII: QN83US2B0N) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ALOE VERA LEAF (UNII: ZY81Z83H0X) DIMETHICONE (UNII: 92RU3N3Y1O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62217-083-59 1 in 1 BLISTER PACK 05/30/2018 1 NDC:62217-083-58 4.25 g in 1 CONTAINER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 05/30/2018 Labeler - Fruit of the Earth, Inc. (079559467)
