NDC | 63354-163-61 |
Set ID | 8fc18bf4-3b1f-45d7-97f8-9a82e0d66246 |
Category | HUMAN OTC DRUG LABEL |
Packager | Edgewell Personal Care Brands LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- Active Ingredients
- Purpose
- Uses
- Warnings
- When using this product
- Stop use and ask a doctor
- Keep out of reach of children.
-
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
- 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 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
- children under 6 months: Ask a doctor.
-
Inactive Ingredients
Ozokerite, Ethylhexyl Palmitate, Caprylic/Capric Triglyceride, Diisobutyl Adipate, Cetyl Alcohol, Cyclopentasiloxane, Theobroma Cacao (Cocoa) Seed Butter, Dimethicone, Isostearyl Linoleate, Cyclohexasiloxane, PEG-8, Silica, Caprylyl Glycol, Sodium Saccharin, BHT, Mineral Oil, PEG-8 Dimethicone, Cocos Nucifera (Coconut) Oil, Aloe Barbadensis Leaf Extract, Carica Papaya (Papaya) Fruit Extract, Colocasia Antiquorum Root Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract, Octyldodecanol, Retinyl Palmitate, Tocopheryl Acetate, Ascorbic Acid, Sodium Propoxyhydroxypropyl Thiosulfate Silica, Propylparaben, Fragrance.
- Other Information
- Questions or comments?
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
BANANA BOAT
avobenzone, octocrylene, oxybenzone stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63354-163 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 100 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 6 g in 100 g Inactive Ingredients Ingredient Name Strength COCOA BUTTER (UNII: 512OYT1CRR) DIMETHICONE (UNII: 92RU3N3Y1O) CYCLOMETHICONE 6 (UNII: XHK3U310BA) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SACCHARIN SODIUM (UNII: SB8ZUX40TY) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) MINERAL OIL (UNII: T5L8T28FGP) PEG-8 DIMETHICONE (UNII: GIA7T764OD) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) PAPAYA (UNII: KU94FIY6JB) MANGO (UNII: I629I3NR86) PASSIFLORA INCARNATA FLOWER (UNII: K8F3G29S6Z) PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H) GUAVA (UNII: 74O70D6VG0) OCTYLDODECANOL (UNII: 461N1O614Y) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ASCORBIC ACID (UNII: PQ6CK8PD0R) PROPYLPARABEN (UNII: Z8IX2SC1OH) CERESIN (UNII: Q1LS2UJO3A) ETHYLHEXYL PALMITATE (UNII: 2865993309) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DIISOBUTYL ADIPATE (UNII: 8OPY05ZY7S) CETYL ALCOHOL (UNII: 936JST6JCN) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63354-163-61 15.6 g in 1 TUBE; Type 0: Not a Combination Product 09/26/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/26/2011 Labeler - Edgewell Personal Care Brands LLC (151179769)