Label: CLEAR DAY SOON SUN- avobenzone, octisalate, octocrylene, and homosalate gel
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Contains inactivated NDC Code(s)
NDC Code(s): 82079-001-30, 82079-001-60 - Packager: Soon Skin Care, 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 August 24, 2021
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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Uses
- Helps prevent sunburn
- If used as directed and with other protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun
- Warnings
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Directions
- Apply generously and evenly to all areas 15 minutes before sun exposure
- Reapply at least every two hours
- Use a water resistant sunscreen if swimming or sweating
- Consult a doctor before use on children under six months of age
Sun Protective Measures
- Spending time in the sun increases your risk of skin cancer and early skin aging
- To decrease this risk regularly use a Broad Spectrum SPF value of 15 or higher and other sun protection measure including: *limit time in the sun from 10 am - 2 pm *wear long-sleeved shirts, pants, hats and sunglasses
- Inactive Ingredients
- Other Information
- Questions or Comments?
- PRINCIPAL DISPLAY PANEL - 30 ml Bottle Box
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INGREDIENTS AND APPEARANCE
CLEAR DAY SOON SUN
avobenzone, octisalate, octocrylene, and homosalate gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82079-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 0.9 mg in 30 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 1.5 mg in 30 mL Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 2.25 mg in 30 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 4.5 mg in 30 mL Inactive Ingredients Ingredient Name Strength Dicaprylyl Carbonate (UNII: 609A3V1SUA) Isostearic Acid (UNII: X33R8U0062) Dibutyl Lauroyl Glutamide (UNII: 3V7K3IA58X) Butyloctyl Salicylate (UNII: 2EH13UN8D3) Dibutyl Ethylhexanoyl Glutamide (UNII: 0IAF2L30VS) .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC) .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) Product Characteristics Color YELLOW Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82079-001-30 1 in 1 BOX 05/06/2021 1 30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:82079-001-60 1 in 1 BOX 05/06/2021 2 60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 05/06/2021 Labeler - Soon Skin Care, Inc. (081073931)