Label: EVERY MAN JACK SPF 30 SUNSCREEN- octisalate, avobenzone, homosalate, octocrylene lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 58443-0360-4 - Packager: Prime Enterprises Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated September 21, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
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INACTIVE INGREDIENTS
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Carbomer, Ethylhexylglycerin, Hydroxypropyl Methylcellulose, Phenoxyethanol, Polyethylene, Polysorbate 20, Propylene Glycol, Sodium Hydroxide, Sorbitan Oleate, Tetrasodium Glutamate Diacetate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Water
- Uses
- Warnings
- Purpose
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Directions
- apply liberally 15 minutes before sun exposure
- reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
- Sun 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 value of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10am-2pm
- wear long sleeve shirts, pants, hats, and sunglasses
- children under 6 months: Ask a doctor
- Other Information
- Questions or Comments?
- Every Man Jack SPF 30 Fragrance Free Sun Protection Lotion
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INGREDIENTS AND APPEARANCE
EVERY MAN JACK SPF 30 SUNSCREEN
octisalate, avobenzone, homosalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0360 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 75.75 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 50.5 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30.3 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) COCOA BUTTER (UNII: 512OYT1CRR) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) PHENOXYETHANOL (UNII: HIE492ZZ3T) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) POLYSORBATE 20 (UNII: 7T1F30V5YH) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) SODIUM HYDROXIDE (UNII: 55X04QC32I) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) SHEA BUTTER (UNII: K49155WL9Y) Product Characteristics Color white (Off white) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0360-4 200 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/04/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 06/04/2020 Labeler - Prime Enterprises Inc. (101946028) Registrant - Prime Enterprises Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises Inc. 101946028 pack(58443-0360) , manufacture(58443-0360) , label(58443-0360) , analysis(58443-0360)