Label: HAWAIIAN TROPIC CARROT PROTECTIVE OIL SPF 30- octocrylene and oxybenzone and avobenzone oil
-
Contains inactivated NDC Code(s)
NDC Code(s): 17630-2039-1 - Packager: Accra-Pac, 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 March 28, 2010
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- INSTRUCCIONES:
-
PRECAUCIONES:
Para uso externo. Puede causar irritación a los ojos. Suspenda su empleo si se presentan signos de irritación o salpullido. No exponer lactantes y niños menores a la radiación solar. Para niños menores de seis (6) meses consulte al médico. La exposición excesiva al sol es un peligro importante para la salud. Inflamable. No pulverizar cerca de llama. No perforar ni incinerar. No exponer al sol ni a temperaturas superiores a 50° C. Proteger los ojos durante la aplicación. Mantener fuera del alcance de los niños. Contiene oxibenzona.
-
INGREDIENTS:
Alcohol Denat., Octocrylene, Benzophenone-3 (Oxybenzone), Butyl Methoxydibenzoylmethane, Acrylates/Octylacrylamide Copolymer, Phenethyl Benzoate, Paraffinum Liquidum, Cocos nucifera, Amyl Acetate, Plumeria acutifolia, Mangifera indica, Psidium guajava, Carica papaya, Passiflora incarnata, Colocasia antiquorum, Retinyl Palmitate, Ascorbic Acid, Tocopheryl Acetate, PEG-8 Dimethicone, Sodium Propoxyhydroxypropyl Thiosulfate Silica, Silica, Octyldodecanol, Aloe barbadensis, Daucus carota sativa, Glycine soja oil, Beta-Carotene, Zea mays, Parfum, Benzyl Alcohol.
-
INGREDIENTES:
Alcohol desnaturalizado, octocrileno, benzofenona-3 (oxibenzona), butil metoxidibenzoilmetano, copolímero de octilacrilamida acrilatos, benzoato de fenil etilo, parafina líquida, Cocos nucifera, acetato de amilo, Plumeria acutifolia, Mangifera indica, Psidium guajava, Carica papaya, Passiflora incarnata, Colocasia antiquorum, dimeticona, propoxihidroxipropil tiosulfato sódico de sílice, sílice, octildodecanol, Aloe barbadensis, Daucus carota sativa, aceite de soja, beta caroteno, Zea mays, perfume, alcohol bencílico.
HECHO EN E.U.A. Fabricado y Comercializado por Energizer Personal Care Products. Importado y distribuido por: EVEREADY DE MÉXICO, S.A. de C.V. Jaime Balmes No. 11, Torre A, Piso 3, Col. Los Morales Polanco, C.P. 11510 México, D.F., R.F.C. EME-861014-J90. Tels. Atención al Consumidor: De Provincia al 01 800 7039900. En el D.F. al 91382057. EVEREADY DE CHILE S.A. Avda. Del Valle 869 Of.02. Edificio Vanguardia – Ciudad Empresarial, Santiago de Chile, Tel.: 597-7900. SCHICK & ENERGIZER PERÚ, S.A. Av. Baquíjano y Carrillo (Ex-Jorge Chávez) N° 336, Miraflores. Lima 18 – Perú. RUC: 20506285586. EVEREADY ECUADOR, C.A. Avda. Interoceánica Km. 4-1/2 (Vía Cumbaya-Miravalle) P.O. Box 17-17-1764, Quito-Ecuador, Telf. (593-2) 2899450. EVEREADY DE COLOMBIA, S.A. Transv. 18 No. 96 – 41 Piso 8 Bogotá - Colombia. ENERGIZER ARGENTINA, S.A. Tucumán 540, Piso 22 “A” C.A.B.A. Legajo No. 2705 Producto Cosmético. Aprobado según Resolución 155/98 Tel. At. al Cons. (011) 4742 - 8193. ENERGIZER GROUP VENEZUELA C.A., Av. Guaicaipuro, Edif Forum, Piso 3, Oficina 3-A, Urbanización El Rosal. Caracas – Venezuela. RIF: J-29586562-7.
© 2009 Tanning Research
Laboratories, LLC
www.hawaiiantropic.com - PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
HAWAIIAN TROPIC CARROT PROTECTIVE OIL SPF 30
octocrylene and oxybenzone and avobenzone oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:17630-2039 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 0.077 mL in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.03 mL in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.02 mL in 1 mL Inactive Ingredients Ingredient Name Strength MINERAL OIL (UNII: T5L8T28FGP) AMYL ACETATE (UNII: 92Q24NH7AS) GUAVA (UNII: 74O70D6VG0) PASSIFLORA INCARNATA TOP (UNII: CLF5YFS11O) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) ASCORBIC ACID (UNII: PQ6CK8PD0R) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) OCTYLDODECANOL (UNII: 461N1O614Y) CARROT (UNII: L56Z1JK48B) SOYBEAN (UNII: L7HT8F1ZOD) BETA CAROTENE (UNII: 01YAE03M7J) BENZYL ALCOHOL (UNII: LKG8494WBH) COCONUT OIL (UNII: Q9L0O73W7L) PLUMERIA EXTRACT (UNII: LGC8P2PC4H) MANGO (UNII: I629I3NR86) ALOE VERA LEAF (UNII: ZY81Z83H0X) CORN OIL (UNII: 8470G57WFM) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17630-2039-1 180 mL in 1 CAN Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 12/15/2009 Labeler - Accra-Pac, Inc. (024213616) Establishment Name Address ID/FEI Business Operations Accra-Pac, Inc. 024213616 MANUFACTURE