DAILY ANTIOXIDANT MOISTURIZER SPF 30. SPF 30 BROAD SPECTRUM SUNSCREEN UVA-UVB- avobenzone, octocrylene, and octisalate lotion

Daily Antioxidant Moisturizer SPF 30. by

Drug Labeling and Warnings

Daily Antioxidant Moisturizer SPF 30. by is a Otc medication manufactured, distributed, or labeled by MDSolarSciences. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Avobenzone 3%	Sunscreen
Octocrylene 2.75%	Sunscreen
Octisalate 5%	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:
  • use a water resistant sunscreen if swimming or sweating
  • at least every 2 hours
• 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 10a.m.-2p.m.
  • Wear long-sleeved shirts, pants, hats and sunglasses

Other Information

Shake well. Rub in well.

• 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 611,
  Pompton Plains, NJ 07444

Inactive Ingredients

Water, Butyloctyl Salicylate, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Dimethicone, Zea Mays (Corn) Oil, Polyester-8, Coco-Caprylate/-Caprate, Polysilicone-15, Sodium Stearoyl Glutamate, Panthenol (Vitamin B-5), Vitis Vinifera (Grape) Callus Culture Extract, Sodium Ascorbyl Phosphate (Vitamin C), Camellia Sinensis Leaf Extract (Green Tea), Aloe Barbadensis Leaf Extract (Aloe Vera), Caffeine, Proline, Phytosphingosine, Ceramide AP, Ceramide EOP, Ceramide NP, Sodium Hyaluronate (Hyaluronic Acid), Allantoin, Chamomilla Recutita (Matricaria) Extract, Niacinamide, Tremella Fuciformis (Mushroom) Extract, Macadamia Integrifolia Seed Oil, Olea Europaea (Olive) Fruit Oil, Rosa Moschata Seed Oil, Lavandula Angustifolia (Lavender) Oil, Diatomaceous Earth, Laminaria Digitata Extract, Ferric Hexapeptide-35, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Caprylic/ Capric Triglyceride, Caprylyl Glycol, Sodium Polyacrylate, Sesamum Indicum (Sesame) Seed Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Teprenone, Lecithin, Mica, Sorbitol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Caprylhydroxamic Acid, Ethylhexylglycerin, Cholesterol, Carbomer, Xanthan Gum, Sodium Lauroyl Lactylate, Sodium Hydroxide, TBHQ, Phenylpropanol, Titanium Dioxide (CI 77891)

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DISTRIBUTED BY
MDSOLARSCIENCES CORP.
GREENS FARMS, CT 06838

PRINCIPAL DISPLAY PANEL - 30 ML Bottle Carton

MDSOLARSCIENCES®

DAILY
ANTIOXIDANT
MOISTURIZER

SPF 30
Broad Spectrum Sunscreen

SPF 3 0

Antioxidants + Niacinamide
Hydrate + Restore

DERMATOLOGIST
DEVELOPED

HYALURONIC ACID
GREEN TEA

CERAMIDES
CHAMOMILE

1 FL OZ / 30 ML

INGREDIENTS AND APPEARANCE

DAILY ANTIOXIDANT MOISTURIZER SPF 30.   SPF 30 BROAD SPECTRUM SUNSCREEN UVA-UVB
avobenzone, octocrylene, and octisalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49358-580
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
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	27.5 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
Glycerin (UNII: PDC6A3C0OX)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
Dimethicone (UNII: 92RU3N3Y1O)
CORN OIL (UNII: 8470G57WFM)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)
Polysilicone-15 (UNII: F8DRP5BB29)
Sodium Stearoyl Glutamate (UNII: 65A9F4P024)
PANTHENOL (UNII: WV9CM0O67Z)
VITIS VINIFERA SEED (UNII: C34U15ICXA)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
Caffeine (UNII: 3G6A5W338E)
Proline (UNII: 9DLQ4CIU6V)
Phytosphingosine (UNII: GIN46U9Q2Q)
Ceramide AP (UNII: F1X8L2B00J)
CERAMIDE 9 (UNII: 88KCS7120E)
Ceramide NP (UNII: 4370DF050B)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
Allantoin (UNII: 344S277G0Z)
CHAMOMILE (UNII: FGL3685T2X)
Niacinamide (UNII: 25X51I8RD4)
TREMELLA FUCIFORMIS FRUITING BODY (UNII: GG8N28393G)
MACADAMIA OIL (UNII: 515610SU8C)
OLIVE OIL (UNII: 6UYK2W1W1E)
Rosa Moschata Seed Oil (UNII: T031ZE559T)
LAVENDER OIL (UNII: ZBP1YXW0H8)
Diatomaceous Earth (UNII: 2RF6EJ0M85)
LAMINARIA DIGITATA (UNII: 15E7C67EE8)
ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)
TEA TREE OIL (UNII: VIF565UC2G)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
Caprylyl Glycol (UNII: 00YIU5438U)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
SESAME OIL (UNII: QX10HYY4QV)
ROSEMARY (UNII: IJ67X351P9)
Teprenone (UNII: S8S8451A4O)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
Mica (UNII: V8A1AW0880)
Sorbitol (UNII: 506T60A25R)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
Caprylhydroxamic Acid (UNII: UPY805K99W)
Ethylhexylglycerin (UNII: 147D247K3P)
Cholesterol (UNII: 97C5T2UQ7J)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
Xanthan Gum (UNII: TTV12P4NEE)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
Sodium Hydroxide (UNII: 55X04QC32I)
TERT-BUTYLHYDROQUINONE (UNII: C12674942B)
PHENYLPROPANOL (UNII: 0F897O3O4M)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49358-580-01	1 in 1 CARTON	07/01/2023
1		30 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	07/01/2023

Labeler - MDSolarSciences (013647301)