NDC | 61995-0027-4 |
Set ID | 6249ff87-5a87-1451-e053-2a91aa0aeadd |
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 - 2.0%
Homosalate - 7.5%
Octocrylene -5.0%
Octyl Salicylate - 3.0%
Close - DOSAGE & ADMINISTRATION
Apply liberally 15 minutes before sun exposure.Use a water resistant sunscreenif swimming or sweating. Reapply 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, Aloe Barbadensis Leaf Juice(1), CalenduCamellia Sinensis Leaf Extract (1), ChamoVitis Venifera (Grape) Seed Extract (1), Tocopheryl Acetate, Cetearyl Olivate, Citric Acid, Sodium Chloride, Sodium Stearoyl Glutamate, Sorbitan Olivate, Xanthan Gum, Alcohol (1), Potassium Sorbate, Sodium Benzoate, BenDehydroacetic Acid, Phenoxyethanol.
(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
J0832706 JASON SUN FACIAL SUNSCREEN SPF20
homosalate, octyl salicylate, octocrylene, avobenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61995-0027 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 HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 7.5 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 3 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 5 g in 100 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) 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) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CETEARYL OLIVATE (UNII: 58B69Q84JO) SODIUM CHLORIDE (UNII: 451W47IQ8X) SORBITAN OLIVATE (UNII: MDL271E3GR) SODIUM BENZOATE (UNII: OJ245FE5EU) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ALOE VERA LEAF (UNII: ZY81Z83H0X) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) GREEN TEA LEAF (UNII: W2ZU1RY8B0) VITIS VINIFERA SEED (UNII: C34U15ICXA) BENZOIC ACID (UNII: 8SKN0B0MIM) DEHYDROACETIC ACID (UNII: 2KAG279R6R) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61995-0027-4 128 g in 1 BOTTLE; Type 0: Not a Combination Product 06/20/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 06/20/2017 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. 014334364 manufacture(61995-0027)