| NDC | 61995-0322-4 |
| Set ID | a5bed94b-2f62-476c-a4b1-aa7c7f093723 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | The Hain Celestial Group, Inc. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
- Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating after towel drying, or at least every 2 hours. Children under 6 months, ask a doctor. Skin Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with Broad Spectrum SPF15 or higher and other protective measures including:
- Limit time in the sun, especially from 10am to 2pm
- Wear long-sleeved shirts, pants, hats and sunglasses.
-
INACTIVE INGREDIENT
Aqua (Water), Cetearyl Alcohol, Glycerin, Cetyl Alcohol, Dimethicone, VP/Hexadecene Copolymer, Caprylic/Capric Triglyceride, Glyceryl Stearate SE, Hydrogenated Palm Kernel Oil, Aloe Barbadensis Leaf Juice (1), Calendula Officinalis Flower Extract (1), Chamomilla Recutita (Matricaria) Flower Extract (1), Cetearyl Olivate, Polysorbate 60, Silica, Sodium Stearoyl Glutamate, Sorbitan Olivate, Tocopheryl Acetate, Xanthan Gum, Alcohol (1), Benzyl Alcohol, Ethylhexylglycerin, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate, Fragrance (Parfum).
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
JASON PURE NATURAL SUN KIDS NATURAL SUNSCREN BROAD SPECTRUM SPF45
homosalate, octocrylene, ethylhexyl methoxycinnamate, ethylhexyl salicylate, titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61995-0322 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 OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 100 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5.0 g in 100 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.0 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERIN (UNII: PDC6A3C0OX) CETYL ALCOHOL (UNII: 936JST6JCN) DIMETHICONE (UNII: 92RU3N3Y1O) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP) ALOE VERA LEAF (UNII: ZY81Z83H0X) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) CHAMOMILE (UNII: FGL3685T2X) CETEARYL OLIVATE (UNII: 58B69Q84JO) POLYSORBATE 60 (UNII: CAL22UVI4M) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) SORBITAN OLIVATE (UNII: MDL271E3GR) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) XANTHAN GUM (UNII: TTV12P4NEE) ALCOHOL (UNII: 3K9958V90M) BENZYL ALCOHOL (UNII: LKG8494WBH) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) PHENOXYETHANOL (UNII: HIE492ZZ3T) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BENZOATE (UNII: OJ245FE5EU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61995-0322-4 113 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/11/2011 Labeler - The Hain Celestial Group, Inc. (858894996) Establishment Name Address ID/FEI Business Operations The Hain Celestial Group, Inc. 858894996 manufacture(61995-0322)
