| NDC | 61995-0830-4 |
| Set ID | 0c3e0fd3-adc6-5ad1-e054-00144ff8d46c |
| Category | HUMAN OTC DRUG LABEL |
| Packager | The Hain Celestial Group, Inc. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- ACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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INACTIVE INGREDIENT
Water, Glycerin, Glyceryl Stearate SE, Cetyl Alcohol, Dimethicone, Cetearyl Alcohol, VP/Hexadecene Copolymer, Caprylic/Capric Triglyceride, Hydrogenated Palm Cernel Oil, Aloe Barbadensis Leaf Juice(1), Camellia Sinensis Leaf Extract (1),Cucumis Sativus (Cucumber) Fruit Extract, Cetearyl Olivate, Polysorbate 60, Lecithin, Silica, Sodium Chloride, Sodium Stearoyl Glutamate, Sorbitan Olivate, Tocopheryl Acetate, Xanthan Gum, Alcohol (1), Citric Acid, Benzyl Alcohol, Ethylhexylglycerin, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate.
(1) Certified Organic Ingredient
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INDICATIONS & USAGE
Helps prevents sunburns. If used as directed with other sun protection measures, decreases risk of skin cancer and early skin aging caused by sun exposure. Skin Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use sunscreen with Broad Spectrum SPF 15 or higher and other protective measures including: limit time in sun, especially from10am to 2pm, and wear long sleeved shirts, pants, hats and sunglases.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
JASON SUN FAMILY SUNSCREEN BROAD SPECTRUM SPF45
homosalate, octinoxate, ethylhexyl salicylate, octocrylene, butul methoxydibenzoylmethane, titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61995-0830 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 7 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1 g in 100 g Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CUCUMBER (UNII: YY7C30VXJT) ALOE VERA LEAF (UNII: ZY81Z83H0X) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) CETYL ALCOHOL (UNII: 936JST6JCN) DIMETHICONE (UNII: 92RU3N3Y1O) XANTHAN GUM (UNII: TTV12P4NEE) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) POLYSORBATE 60 (UNII: CAL22UVI4M) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CETEARYL OLIVATE (UNII: 58B69Q84JO) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) SORBITAN OLIVATE (UNII: MDL271E3GR) SODIUM BENZOATE (UNII: OJ245FE5EU) ALCOHOL (UNII: 3K9958V90M) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) BENZYL ALCOHOL (UNII: LKG8494WBH) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61995-0830-4 113 g in 1 TUBE; Type 0: Not a Combination Product 03/10/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/10/2014 Labeler - The Hain Celestial Group, Inc. (858894996) Registrant - The Hain Celestial Group, Inc. (858894996) Establishment Name Address ID/FEI Business Operations The Hain Celestial Group, Inc. 858894996 manufacture(61995-0830)
