Label: DAILY ANTI-AGING MOISTURIZER BROAD SPECTRUM SPF30 SUNSCREEN UVA-UVB SUNSCREEN WITH SOLSCI-X- avobenzone, octisalate, and octocrylene lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 49358-555-01, 49358-555-02 - Packager: MDSolarSciences
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 26, 2018
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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 with other sun 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 liberally 15 minutes before sun exposure
- Reapply:
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- At least every 2 hours
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- Use a water resistant sunscreen if swimming or sweating
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- Immediately after towel drying
- Children under 6 months: Ask a doctor
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Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with Broad Spectrum SPF of 15 or higher and other sun protection measures including:
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- Limit time in the sun, especially from 10 a.m. - 2 p.m.
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- Wear long-sleeved shirts, pants, hats and sunglasses
- Other information
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Inactive ingredients
Water, Butyloctyl Salicylate, Coco-Caprylate/Caprate, Glycerin, Sorbitol, Lecithin, Aloe Barbadensis Leaf Extract, Caffeine, Zea Mays (Corn) Oil, Proline, Xanthan Gum, Sodium Ascorbyl Phosphate, Rosa Moschata Seed Oil, Niacinamide, Vitis Vinifera (Grape) Callus Culture Extract, Chamomilla Recutita (Matricaria) Flower Extract, Camellia Sinensis (Green Tea) Extract, Diatomaceous Earth, Helianthus Annuus (Sunflower) Seed Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Laminaria Digitata Extract, Tremella Fuciformis (Mushroom) Extract, Ferric Hexapeptide-35, Sesamum Indicum (Sesame) Seed Oil, Macadamia Integrifolia Seed Oil, Olea Europaea (Olive) Fruit Oil, Polysilicone-15, Sodium Hyaluronate, Dimethicone, Ceteareth-25, Cetyl Alcohol, Behenic Acid, Cholesterol, Ceramide NP, Ceramide NS, Ceramide EOS, Ceramide EOP, Ceramide AP, Caprooyl Phytosphingosine, Caprooyl Sphingosine, Caprylic/ Capric Triglyceride, Teprenone, Sodium Stearoyl Glutamate, Polyester-8, Caprylhydroxamic Acid, Caprylyl Glycol, Carbomer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Panthenol, Sodium Polyacrylate, Mica, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Lavandula Angustifolia (Lavender) Oil, Sodium Hydroxide
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
DAILY ANTI-AGING MOISTURIZER BROAD SPECTRUM SPF30 SUNSCREEN UVA-UVB SUNSCREEN WITH SOLSCI-X
avobenzone, octisalate, and octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49358-555 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 30 mg in 1 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 50 mg in 1 mL Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 27.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Butyloctyl Salicylate (UNII: 2EH13UN8D3) Coco-Caprylate/Caprate (UNII: 8D9H4QU99H) Glycerin (UNII: PDC6A3C0OX) Sorbitol (UNII: 506T60A25R) Hydrogenated Soybean Lecithin (UNII: H1109Z9J4N) Aloe Vera Leaf (UNII: ZY81Z83H0X) Caffeine (UNII: 3G6A5W338E) Corn Oil (UNII: 8470G57WFM) Proline (UNII: 9DLQ4CIU6V) Xanthan Gum (UNII: TTV12P4NEE) Sodium Ascorbyl Phosphate (UNII: 836SJG51DR) Rosa Moschata Seed Oil (UNII: T031ZE559T) Niacinamide (UNII: 25X51I8RD4) Vitis Vinifera Seed (UNII: C34U15ICXA) Chamomile (UNII: FGL3685T2X) Green Tea Leaf (UNII: W2ZU1RY8B0) Diatomaceous Earth (UNII: 2RF6EJ0M85) Helianthus Annuus Flowering Top (UNII: BKJ0J3D1BP) Rosemary (UNII: IJ67X351P9) Laminaria Digitata (UNII: 15E7C67EE8) Tremella Fuciformis Fruiting Body (UNII: GG8N28393G) Acetyl Hexapeptide-8 (UNII: L4EL31FWIL) Sesame Oil (UNII: QX10HYY4QV) Macadamia Oil (UNII: 515610SU8C) Olive Oil (UNII: 6UYK2W1W1E) Polysilicone-15 (UNII: F8DRP5BB29) Hyaluronate Sodium (UNII: YSE9PPT4TH) Dimethicone (UNII: 92RU3N3Y1O) Ceteareth-25 (UNII: 8FA93U5T67) Cetyl Alcohol (UNII: 936JST6JCN) Behenic Acid (UNII: H390488X0A) Cholesterol (UNII: 97C5T2UQ7J) Ceramide NP (UNII: 4370DF050B) Ceramide NG (UNII: C04977SRJ5) 3-Dehydroxy Ceramide 1 (UNII: CR0J8RN66K) Ceramide 9 (UNII: 88KCS7120E) Ceramide AP (UNII: F1X8L2B00J) Caprooyl Tetrapeptide-3 (UNII: LZI0HJ3K2R) N-Hexanoylsphingosine (UNII: 038753E78J) Medium-Chain Triglycerides (UNII: C9H2L21V7U) Teprenone (UNII: S8S8451A4O) Sodium Stearoyl Glutamate (UNII: 65A9F4P024) Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) (UNII: T9296U138P) Caprylhydroxamic Acid (UNII: UPY805K99W) Caprylyl Glycol (UNII: 00YIU5438U) Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked) (UNII: 4Q93RCW27E) Carbomer Interpolymer Type A (Allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO) Allantoin (UNII: 344S277G0Z) Panthenol (UNII: WV9CM0O67Z) Sodium Polyacrylate (8000 MW) (UNII: 285CYO341L) Mica (UNII: V8A1AW0880) Tea Tree Oil (UNII: VIF565UC2G) Lavender Oil (UNII: ZBP1YXW0H8) Sodium Hydroxide (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49358-555-01 1 in 1 CARTON 03/01/2016 1 50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 2 NDC:49358-555-02 1 in 1 CARTON 03/01/2016 2 15 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 03/01/2016 Labeler - MDSolarSciences (013647301)
