LIGHT DAY SUNSCREEN BROAD SPECTRUM SPF 37- avobenzone, octinoxate and octocrylene lotion

Light Day Sunscreen Broad Spectrum SPF 37 by

Drug Labeling and Warnings

Light Day Sunscreen Broad Spectrum SPF 37 by is a Otc medication manufactured, distributed, or labeled by Circadia by Dr Pugliese, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Avobenzone 3.0%

Octinoxate 7.5%

Octocrylene 2.8%

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
• When using this product keep out of eyes. Rinse with water to remove.
• Stop use and ask a doctor if rash occurs.
• Do not use on damaged or broken skin
• Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally to skin 15 minutes before sun exposure and as
  needed.
• use a water resistant sunscreen if swimming or sweating.
• reapply 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 this risk, regularly use a sunscreen with a Broad Spectrum SPF 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 shirt, pants, hats, and sunglasses

Inactive ingredients

Water, C12-15 Alkyl Benzoate, Ethylhexyl Methoxycrylene, Glycerin, Silica, Eicosene Copolymer, Glyceryl Stearate, PEG-100 Stearate, Potassium Cetyl Phosphate, Dimethicone, Cyclopentasiloxane, Cyclohexasiloxane, Dimethyl Capramide, Hydrogenated Palm Glycerides, Polysiloxane 11, Dimethylmethoxy Chromanol, Acrylamide/Sodium Acryloyldimethyl Taurate Copolymer, Diaminopropionoyl Tripeptide-33, Caprylyl Glycol, Disodium EDTA, Xanthan Gum, Methylisothiazolinone, Hexylene Glycol, Isohexadecane, Polysorbate 80, Vitis Vinifera Fruit Cell Extract, Isomalt, Prunus Armeniaca (Apricot) Fruit Extract, Lecithin, Sodium Benzoate, Aniba Rosaeodora (Rosewood) Wood Extract, Citrus Aurantifolia (Lime) Peel Extract, Citrus Aurantium Dulcis (Orange) Peel Extract, Vanilla Planifolia Fruit Extract, Citrus Grandis (Grapefruit) Peel Extract, Cocos Nucifera (Coconut) Oil

Other Information

• protect this product from excessive heat and direct sun.

Questions?

Call toll-free (800) 630-4710

Package/Label Principal Display Panel

Light Day Sunscreen for face & neck

Broad Spectrum SPF37

Advanced Professional Skincare

2 fl oz (59 ml)

Circadia by Dr. Pugliese, Inc.
8371 Route 183 Bethel, PA 19507
Circadia.com

Bottle Label

INGREDIENTS AND APPEARANCE

LIGHT DAY SUNSCREEN BROAD SPECTRUM SPF 37 
avobenzone, octinoxate and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76458-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.03 mL  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.075 mL  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.028 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
EDETATE DISODIUM (UNII: 7FLD91C86K)
XANTHAN GUM (UNII: TTV12P4NEE)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
ISOHEXADECANE (UNII: 918X1OUF1E)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ISOMALT (UNII: S870P55O2W)
APRICOT (UNII: 269CJD5GZ9)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ANIBA ROSAEODORA WOOD (UNII: NE01NKA8B2)
LIME PEEL (UNII: 544EQK5Q0W)
ORANGE PEEL (UNII: TI9T76XD44)
VANILLA (UNII: Q74T35078H)
CITRUS MAXIMA FRUIT RIND (UNII: 5NX3G75CA6)
COCONUT OIL (UNII: Q9L0O73W7L)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
WINE GRAPE (UNII: 3GOV20705G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76458-201-02	59 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/15/2012

Labeler - Circadia by Dr Pugliese, Inc. (013694423)