Label: NO-AD 45 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 70281-102-44 - 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 February 15, 2018
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- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
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Uses
- helps prevent sunburn
- if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
- helps prevent sunburn
- 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
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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 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 sunglasses
- children under 6 months: Ask a doctor
- apply liberally 15 minutes before sun exposure
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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, 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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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
NO-AD 45 SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70281-102 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 10 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2 g in 100 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 5 g in 100 g Inactive Ingredients Ingredient Name Strength COCOA BUTTER (UNII: 512OYT1CRR) CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) ALOE VERA LEAF (UNII: ZY81Z83H0X) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) ETHYLHEXYL PALMITATE (UNII: 2865993309) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERIN (UNII: PDC6A3C0OX) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) PHENOXYETHANOL (UNII: HIE492ZZ3T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70281-102-44 475 g in 1 BOTTLE; Type 0: Not a Combination Product 09/15/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 09/15/2015 Labeler - SolSkyn Personal Care LLC (080010329)