Description: SUNTONE SPF 50- avobenzone, homosalate, octisalate, octocrylene lotion Prime Enterprises, Inc. 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.----------Suntone Kids Sunscreen Lotion Broad Spectrum SPF50Active ingredientsAvobenzone 3%Homosalate 10%Octisalate 5%Octocrylene 5%PurposeSunscreenUseshelps prevent sunburnif used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sunWarningsFor external use only.Do not use on damaged or broken skinWhen using this product keep out of eyes. Rinse with water to remove. Keep away from dace to avoid breathing it.Stop use and ask a doctor if rash occursKeep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.Directionsapply liberally 15 minutes before sun exposurereapply:after 80 minutes of swimming or sweatingimmediately after towel dryingat least every 2 hoursSun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:limit time in the sun, especially from 10 a.m. - 2 p.m.wear long-sleeve shirts, pants, hats, and sunglasseschildren under 6 months: Ask a doctorInactive ingredientsAcrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, C12-15 Alkyl Benzoate, Carbomer, Disodium EDTA, Ethylhexylglycerin, Fragrance, Hydroxypropyl Methylcellulose, Phenoxyethanol, Polyethylene, Polysorbate 20, Propylene Glycol, Sodium Hydroxide, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, WaterOther informationProtect form excessive heat and direct sunmay stain or damage some fabrics or surfacesQuestions or comments?Biocycle Laboratories, Inc.16363 NW 49 Avenue, Miami, FL 33014Suntone Kids Sunscreen Lotion Broad Spectrum SPF50SUNTONE SPF 50 avobenzone, homosalate, octisalate, octocrylene lotionProduct InformationProduct TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0524Route of AdministrationTOPICALActive Ingredient/Active MoietyIngredient NameBasis of StrengthStrengthHOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)HOMOSALATE98 mg in 1 mLOCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)OCTISALATE49 mg in 1 mLOCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)OCTOCRYLENE49 mg in 1 mLAVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)AVOBENZONE29.4 mg in 1 mLInactive IngredientsIngredient NameStrengthEDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) HYPROMELLOSES (UNII: 3NXW29V3WO) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALOE VERA LEAF (UNII: ZY81Z83H0X) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYSORBATE 20 (UNII: 7T1F30V5YH) SODIUM HYDROXIDE (UNII: 55X04QC32I) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) COCOA BUTTER (UNII: 512OYT1CRR) WATER (UNII: 059QF0KO0R) Product CharacteristicsColorwhite (White to Off White)Score ShapeSizeFlavorImprint CodeContains Packaging#Item CodePackage DescriptionMarketing Start DateMarketing End Date1NDC:58443-0524-4177 mL in 1 BOTTLE; Type 0: Not a Combination Product02/09/2021Marketing InformationMarketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End DateOTC monograph finalpart35202/09/2021Labeler - Prime Enterprises, Inc. (101946028)Registrant - Prime Enterprises, Inc. (101946028)EstablishmentNameAddressID/FEIBusiness OperationsPrime Enterprises, Inc.101946028manufacture(58443-0524) , label(58443-0524) , analysis(58443-0524) , pack(58443-0524)
Price: 11.99 USD
Location: Lakewood, New Jersey
End Time: 2024-10-06T17:53:13.000Z
Shipping Cost: 9.85 USD
Product Images
Item Specifics
Restocking Fee: No
Return shipping will be paid by: Buyer
All returns accepted: Returns Accepted
Item must be returned within: 30 Days
Refund will be given as: Money Back
Expiration Date: 04/2025
Size: 6 Oz
UVA Protection: Broad Spectrum
MPN: Unknown
Bundle Listing: No
Sun Protection Factor (SPF): SPF 50
Brand: Suntone
Department: BABY
Type: Physical (Mineral) Sunscreen
Volume: 6 oz
Formulation: Lotion, Spray
Body Area: Full Body
Features: Free from Oxybenzone & Octinoxote
Country/Region of Manufacture: United States
Product Line: Suntone
