DAILY ANTI-AGING MOISTURIZER BROAD SPECTRUM SPF30 SUNSCREEN UVA-UVB SUNSCREEN WITH SOLSCI-X- avobenzone, octisalate, and octocrylene lotion

Daily Anti-Aging Moisturizer by

Drug Labeling and Warnings

Daily Anti-Aging Moisturizer by is a Otc medication manufactured, distributed, or labeled by MDSolarSciences. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients:	Purpose
Avobenzone 3%	Sunscreen
Octisalate 5%	Sunscreen
Octocrylene 2.75%	Sunscreen

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

For external use only

Do not use on damaged or broken skin

Stop use and ask a doctor if rash occurs

When using this product keep out of eyes. Rinse with water to remove

Keep out of reach of children.

If swallowed get medical help or contact a Poison Control Center right away.

Directions

• Apply liberally 15 minutes before sun exposure
• Reapply:
  • - At least every 2 hours
  • - Use a water resistant sunscreen if swimming or sweating
  • - Immediately after towel drying
• Children under 6 months: Ask a doctor
• 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:
  • - Limit time in the sun, especially from 10 a.m. - 2 p.m.
  • - Wear long-sleeved shirts, pants, hats and sunglasses

Other information

• Protect the product in this container from excessive heat and direct sunlight
• May stain some fabrics
• You may report serious adverse reactions to: Report Reaction, LLC. PO Box 22, Plainsboro, NJ 08536-0222

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

Distributed by:
MDSolarSciences Corp.
40 Richards Avenue, 3rd Fl.
Norwalk, CT 06854

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

MDSolarSciences™

30

DAILY
ANTI-AGING
MOISTURIZER
with SolSci-X™

BROAD SPECTRUM
SPF 30
UVA-UVB SUNSCREEN

+R
enhanced with
ProVention-R™

developed & approved
by Dermatologists

Non-comedogenic – won't clog pores

sun repair

50 mL - 1.7 Fl. Oz.

INGREDIENTS AND APPEARANCE

DAILY ANTI-AGING MOISTURIZER   BROAD SPECTRUM SPF30 SUNSCREEN UVA-UVB SUNSCREEN WITH SOLSCI-X
avobenzone, octisalate, and octocrylene lotion

Product 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)