Label: ATTITUDE - LEAVES BAR - LIP BALM - SPF 15 - MANGO- zinc oxide stick
- NDC Code(s): 61649-983-01
- Packager: Attitude DBA 9055-7588 Québec Inc.
- Category: HUMAN OTC DRUG LABEL
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 July 10, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Medicinal ingredient
- Purpose
-
Uses
- Helps prevent sunburn
- If used as directed with other sun protection measures ( see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
- Warnings
- Directions
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Inactive or non-medicinal ingredients
cocos nucifera (coconut) oil, polyhydroxystearic acid, butyrospermum parkii (shea) butter, helianthus annuus (sunflower) seed oil, helianthus annuus (sunflower) seed wax, behenyl behenate, caprylic/capric triglyceride, ricinus communis (castor) seed oil, argania spinosa kernel oil, flavor, euphorbia cerifera (candelilla) wax, coco-caprylate/caprate, rosmarinus officinalis (rosemary) leaf extract, caprylic/capric triglyceride 1, vanillin 1, 3-hexenol 1, hexyl hexanoate 1, alpha pinene 1.
- 1
- *flavour
- Other Information
- PRINCIPAL DISPLAY PANEL - 8.5 g Tube Carton
-
INGREDIENTS AND APPEARANCE
ATTITUDE - LEAVES BAR - LIP BALM - SPF 15 - MANGO
zinc oxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61649-983 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 10 g in 100 g Inactive Ingredients Ingredient Name Strength COCONUT OIL (UNII: Q9L0O73W7L) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) SHEA BUTTER (UNII: K49155WL9Y) SUNFLOWER OIL (UNII: 3W1JG795YI) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) BEHENYL BEHENATE (UNII: K8NU647RJ0) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CASTOR OIL (UNII: D5340Y2I9G) ARGAN OIL (UNII: 4V59G5UW9X) CANDELILLA WAX (UNII: WL0328HX19) COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H) ROSEMARY (UNII: IJ67X351P9) VANILLIN (UNII: CHI530446X) 3-HEXEN-1-OL, (3Z)- (UNII: V14F8G75P4) HEXYL HEXANOATE (UNII: GI6FE1QMW6) .ALPHA.-PINENE (UNII: JPF3YI7O34) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61649-983-01 8.5 g in 1 TUBE; Type 0: Not a Combination Product 08/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 02/04/2022 Labeler - Attitude DBA 9055-7588 Québec Inc. (201137051) Establishment Name Address ID/FEI Business Operations Attitude DBA 9055-7588 Québec Inc. 204307099 manufacture(61649-983) , label(61649-983) , pack(61649-983) , analysis(61649-983)