Label: NOAD SPORT SPF 50- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 70281-183-47 - Packager: Solskyn Personal Care LLC
- 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 October 8, 2019
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
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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 broad spectrum of SPF of 15 or higher and other sun protection measures including:
• limit time in the sun, especially 10a.m.-2a.m.
• wear long-sleeved shirts, pants, hats and sunglasses
•Children under 6 months: Ask a doctor
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Inactive Ingredients
Acrylates Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe
Barbadensis Leaf Extract, C12-15 Alkyl Benzoate, Carbomer, Disodium EDTA,
Ethylhexyl Palmitate, Ethylhexylglycerin, Fragrance, Glycerin, Hydroxypropyl
Methylcellulose, Phenoxyethanol, Propylene Glycol, Sorbitan Oleate, Theobroma
Cacao (Cocoa) Seed Butter, Tocopheryl (Vitamin E) Acetate, Triethanolamine, Water
- Other Information
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INGREDIENTS AND APPEARANCE
NOAD SPORT SPF 50
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70281-183 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.5 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 5 g in 100 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 6 g in 100 g Inactive Ingredients Ingredient Name Strength METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) ETHYLHEXYL PALMITATE (UNII: 2865993309) GLYCERIN (UNII: PDC6A3C0OX) 2-HYDROXYPROPYL METHACRYLATE (UNII: V9B8S034AW) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCOA BUTTER (UNII: 512OYT1CRR) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TROLAMINE (UNII: 9O3K93S3TK) ALOE VERA LEAF (UNII: ZY81Z83H0X) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70281-183-47 475 g in 1 CONTAINER; Type 0: Not a Combination Product 10/07/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 10/07/2019 Labeler - Solskyn Personal Care LLC (080010329) Establishment Name Address ID/FEI Business Operations KIK Piedmont LLC 078482780 manufacture(70281-183)
