SERIOUS SKINCARE SERIOUS C3 PLASMA BIO TECHNOLOGY C VITAMIN C ESTER PROTECTIVE DAYTIME BROAD SPECTRUM MOISTURIZER SPF 30- avobenzone, octocrylene, octinoxate, octisalate, oxybenzone cream

SERIOUS SKINCARE SERIOUS C3 PLASMA BIO TECHNOLOGY C VITAMIN C ESTER PROTECTIVE DAYTIME BROAD SPECTRUM MOISTURIZER SPF 30 by

Drug Labeling and Warnings

SERIOUS SKINCARE SERIOUS C3 PLASMA BIO TECHNOLOGY C VITAMIN C ESTER PROTECTIVE DAYTIME BROAD SPECTRUM MOISTURIZER SPF 30 by is a Otc medication manufactured, distributed, or labeled by Flageoli Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Avobenzone 3%
Octocrylene 2.7%
Octinoxate 7.5%
Octisalate 5%
Oxybenzone 5%

Purpose

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

When using this product 

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if 

rash occurs

Keep out of reach of children.

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

Directions

• Apply liberally and evenly 15 minutes before sun exposure
• Reapply at least every 2 hours
• Use a water resistant sunscreen if swimming or sweating
• Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value 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
• Children under 6 months of age: Ask a doctor

Other information

Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

Water (aqua), C12-15 alkyl benzoate, caprylic/capric triglyceride, glycerin, dimethicone, potassium cetyl phosphate, cetearyl alcohol, glyceryl stearate, PEG-100 stearate, tocopherol, anogeissus leiocarpus bark extract, mandarin orange (citrus nobilis) peel extract, lemon (citrus medica limonum) fruit extract, acerola (malpighia glabra) fruit extract, hydrolyzed collagen, maltodextrin, urea, alpha-glucan oligosaccharide, creatine, lime (citrus aurantifolia) fruit extract, lactic acid, ascorbic acid, hydroxyapatite, glutathione, cysteine, hydrolyzed vegetable protein, passiflora incarnata extract, hydroxyethylcellulose, magnesium aluminum silicate, sodium ascorbyl phosphate, caprylyl glycol, sodium citrate, sodium polyacrylate,
disodium edta, propanediol, pentylene glycol, butylene glycol, lecithin, hydroxyphenyl propamidobenzoic acid, ascorbyl palmitate, tetrahexyldecyl ascorbate, 3-o-ethyl ascorbic acid, magnesium ascorbyl phosphate, potassium ascorbyl tocopheryl phosphate, magnesium aspartate, zinc gluconate, ethoxydiglycol, zeolite, silica, sodium chloride, tetrasodium glutamate diacetate, calcium gluconate, copper gluconate, acetyl tetrapeptide-17 (and) colloidal platinum, ethylhexylglycerin, citric acid, fragrance (parfum), phenoxyethanol, sodium hydroxymethylglycinate, sodium benzoate, potassium sorbate.

Package Labeling:

INGREDIENTS AND APPEARANCE

SERIOUS SKINCARE SERIOUS C3 PLASMA BIO TECHNOLOGY C VITAMIN C ESTER PROTECTIVE DAYTIME BROAD SPECTRUM MOISTURIZER SPF 30 
avobenzone, octocrylene, octinoxate, octisalate, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53755-101
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 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
TOCOPHEROL (UNII: R0ZB2556P8)
ANOGEISSUS LEIOCARPUS BARK (UNII: U5TP1X38RH)
CITRUS NOBILIS (UNII: 8MFF77J91V)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
UREA (UNII: 8W8T17847W)
.ALPHA.-GLUCAN OLIGOSACCHARIDE (UNII: S95658MI3W)
CREATINE (UNII: MU72812GK0)
LIME (CITRUS) (UNII: 8CZS546954)
LACTIC ACID (UNII: 33X04XA5AT)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
GLUTATHIONE (UNII: GAN16C9B8O)
CYSTEINE (UNII: K848JZ4886)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
PROPANEDIOL (UNII: 5965N8W85T)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
3-O-ETHYL ASCORBIC ACID (UNII: 6MW60CB71P)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE (UNII: 61R4GJ48ER)
MAGNESIUM ASPARTATE (UNII: R17X820ROL)
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
CALCIUM GLUCONATE (UNII: SQE6VB453K)
COPPER GLUCONATE (UNII: RV823G6G67)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM HYDROXYMETHYLGLYCINATE (UNII: DIG6BWZ9XT)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53755-101-04	1 in 1 BOX	04/13/2017
1		120 mL in 1 TUBE; 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	04/13/2017

Labeler - Flageoli Limited (036999498)