![J0832212 JASON KIDS SUNSCREEN SPF45 (HOMOSALATE, OCTYL SALICYLATE, OCTOCRYLENE, AVOBENZONE) LOTION [THE HAIN CELESTIAL GROUP, INC.]](https://medic.hrt.org//dailymed/images/61fc5ec4-094c-f4c9-e053-2a91aa0aab29/J0832212 Jason Kids Sunscreen SPF45 tube label.jpg)
| NDC | 61995-0022-4 |
| Set ID | 61fc5ec4-094c-f4c9-e053-2a91aa0aab29 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | The Hain Celestial Group, Inc. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- ACTIVE INGREDIENT
Active Ingredient
Avobenzone - 3%
Homosalate - 10.0%
Octocrylene -10.0%
Octyl Salicylate - 5.0%
Close - DOSAGE & ADMINISTRATION
Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours. Children under 6 months, ask a doctor
Close - PURPOSE
- WARNINGS
For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if skin rash occurs.
Close - KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children. If swallowed get medical help or contact Poison Center right away.
Close - INACTIVE INGREDIENT
Water, Cetyl Alcohol, Glycerin, Caprylic/Capric Triglyceride, Glyceryl Stearate SE, Dimethicone, VP/Hexadecene Copolymer, Cananga Odorata Flower Oil, Citrus Aurantium Dulcis (Orange) Flower Oil, Aloe Barbadensis Leaf Juice(1), Calendula Officinalis Flower Extract (1), Chamomilla Recutita 9Matricaria) Flower Extract (1), Tocopheryl Acetate, Allyl Caproate, Cetearyl Alcohol, Cetearyl Olivate, Citric Acid, Ethyl Acetate, Gamma-Nonelactone, Isoamyl Acetate, Polysorbate 60, Sodium Chloride, Sodium Stearoyl Glutamate, Sorbitan Olivate, Vanillin, Xanthan Gum, Benzyl Alcohol, Potassium Sorbate, Sodium Benzoate, Benzyl Benzoate, Limonene, Linalool.
(1) Certified Organic Ingredient
Close - 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.
Close - INGREDIENTS AND APPEARANCE
J0832212 JASON KIDS SUNSCREEN SPF45
homosalate, octyl salicylate, octocrylene, avobenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61995-0022 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 g 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 10 g in 100 g Inactive Ingredients Ingredient Name Strength .GAMMA.-NONALACTONE (UNII: I1XGH66S8P) ALLYL HEXANOATE (UNII: 3VH84A363D) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) 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) POLYSORBATE 60 (UNII: CAL22UVI4M) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CETEARYL OLIVATE (UNII: 58B69Q84JO) SODIUM CHLORIDE (UNII: 451W47IQ8X) SORBITAN OLIVATE (UNII: MDL271E3GR) SODIUM BENZOATE (UNII: OJ245FE5EU) BENZYL ALCOHOL (UNII: LKG8494WBH) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ALOE VERA LEAF (UNII: ZY81Z83H0X) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) CANANGA OIL (UNII: 8YOY78GNNX) BENZYL BENZOATE (UNII: N863NB338G) ORANGE OIL (UNII: AKN3KSD11B) ETHYL ACETATE (UNII: 76845O8NMZ) ISOAMYL ACETATE (UNII: Z135787824) VANILLIN (UNII: CHI530446X) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61995-0022-4 113 g in 1 TUBE; Type 0: Not a Combination Product 12/07/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 12/07/2017 Labeler - The Hain Celestial Group, Inc. (858894996) Registrant - The Hain Celestial Group, Inc. (858894996) CloseEstablishment Name Address ID/FEI Business Operations The Hain Celestial Group, Inc. 014334364 manufacture(61995-0022)