TINT PLUS TONE SPF 50. SPF 50 BROAD SPECTRUM SUNSCREEN SHEER TINTED MOISTURIZER- avobenzone, octisalate, and octocrylene lotion

Tint plus Tone SPF 50. by

Drug Labeling and Warnings

Tint plus Tone SPF 50. 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:
  • 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, Sodium Hyaluronate (Hyaluronic Acid), Panthenol (Vitamin B-5), Ceramide NP, Ceramide AP, Ceramide EOP, Phytosphingosine, Caffeine, Sodium Ascorbyl Phosphate (Vitamin C), Niacinamide, Vitis Vinifera (Grape) Callus Culture Extract, Camellia Sinensis Leaf Extract (Green Tea), Aloe Barbadensis Leaf Extract (Aloe Vera), Proline, Allantoin, Chamomilla Recutita (Matricaria) Extract, Tremella Fuciformis (Mushroom) Extract, Macadamia Integrifolia Seed Oil, Olea Europaea (Olive) Fruit Oil, Rosa Moschata (Rosehip) Seed Oil, Lavandula Angustifolia (Lavender) Oil, Diatomaceous Earth, Laminaria Digitata (Seaweed) Extract, Sesamum Indicum (Sesame) Seed Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Ferric Hexapeptide-35, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Caprylic/ Capric Triglyceride, Caprylyl Glycol, Sodium Polyacrylate, Teprenone, Lecithin, Sorbitol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Caprylhydroxamic Acid, Cholesterol, Ethylhexylglycerin, Xanthan Gum, Carbomer, Sodium Hydroxide, TBHQ, Phenylpropanol, Sodium Lauroyl Lactylate, May Contain: Synthetic Fluorphlogopite, CI 77891, CI 77499, CI 77492, CI 77491, CI 77861, CI 77019

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY
MDSOLARSCIENCES CORP.
GREENS FARMS, CT 06838

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

MDSOLARSCIENCES®

TINT
+
TONE

Broad Spectrum SPF 50
Sheer Tinted Moisturizer

SPF 50

Skin-Refining, Sheer
Tinted Moisturizer; Vitamin C,
Green Tea and Rosehip

DERMATOLOGIST
DEVELOPED

CERAMIDES
CAFFEINE

MUSHROOM EXTRACT
HYLAURONIC ACID

1.7 FL OZ / 50 ML

INGREDIENTS AND APPEARANCE

TINT PLUS TONE SPF 50.   SPF 50 BROAD SPECTRUM SUNSCREEN SHEER TINTED MOISTURIZER
avobenzone, octisalate, and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49358-582
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)
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)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PANTHENOL (UNII: WV9CM0O67Z)
CERAMIDE NP (UNII: 4370DF050B)
CERAMIDE AP (UNII: F1X8L2B00J)
CERAMIDE 9 (UNII: 88KCS7120E)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
CAFFEINE (UNII: 3G6A5W338E)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
NIACINAMIDE (UNII: 25X51I8RD4)
VITIS VINIFERA SEED (UNII: C34U15ICXA)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PROLINE (UNII: 9DLQ4CIU6V)
ALLANTOIN (UNII: 344S277G0Z)
CHAMOMILE (UNII: FGL3685T2X)
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)
SESAME OIL (UNII: QX10HYY4QV)
ROSEMARY (UNII: IJ67X351P9)
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)
TEPRENONE (UNII: S8S8451A4O)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
SORBITOL (UNII: 506T60A25R)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CHOLESTEROL (UNII: 97C5T2UQ7J)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
XANTHAN GUM (UNII: TTV12P4NEE)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
TERT-BUTYLHYDROQUINONE (UNII: C12674942B)
PHENYLPROPANOL (UNII: 0F897O3O4M)

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
May contain	MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
May contain	TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
May contain	FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
May contain	FERRIC OXIDE RED (UNII: 1K09F3G675)
May contain	STANNIC OXIDE (UNII: KM7N50LOS6)
May contain	FERROSOFERRIC OXIDE (UNII: XM0M87F357)
May contain	MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49358-582-01	1 in 1 CARTON	07/01/2023
1		50 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)