LUMIPEARL PERFECT AND PROTECT DAY BROAD SPECTRUM SPF 25 SUNSCREEN- homosalate, octisalate, oxybenzone, avobenzone, and octocrylene cream

LUMIPEARL PERFECT AND PROTECT DAY BROAD SPECTRUM SPF 25 SUNSCREEN by

Drug Labeling and Warnings

LUMIPEARL PERFECT AND PROTECT DAY BROAD SPECTRUM SPF 25 SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by Guthy-Renker LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredients

Avobenzone 3.0%
Homosalate 8.0%
Octisalate 5.0%
Octocrylene 2.7%
Oxybenzone 3.0%

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

Directions

• Apply liberally to face and neck 15 minutes prior to sun exposure.
• 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 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-sleeve shirts, pants, hats, and sunglasses

Inactive ingredients

Water, C12-15 Alkyl Benzoate, Cyclopentasiloxane, Propanediol, Silica, Sea Water (Maris Aqua), Cetearyl Alcohol, Dimethicone, Potassium Cetyl Phosphate, Phormidium Persicinum Extract, Sodium PCA, Tribehenin PEG-20 Esters, Sodium Hyaluronate, Nacre Protein, Glycerin, Nacre Lipids, Glyceryl Stearate, PEG-100 Stearate, Calcium Carbonate, Polysilicone-15, Disodium EDTA, Carbomer, Aminomethyl Propanol, Phenoxyethanol, Caprylyl Glycol, Chlorphenesin, Fragrance.

Other information

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

Questions or Comments?

Within US 1-888-920-7477

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Dist. by Guthy-Renker® LLC.
100 N Sepulveda Blvd., El Segundo, CA 90245.

PRINCIPAL DISPLAY PANEL - 50 mL Tube Label

LUMIPEARL™

PERFECT & PROTECT
DAY CREAM

BROAD SPECTRUM
SPF 25 SUNSCREEN

1.7 FL. OZ. / 50mL

INGREDIENTS AND APPEARANCE

LUMIPEARL PERFECT AND PROTECT DAY BROAD SPECTRUM SPF 25 SUNSCREEN 
homosalate, octisalate, oxybenzone, avobenzone, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70605-041
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	8 mg  in 100 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	5 mg  in 100 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	3 mg  in 100 mL
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	3 mg  in 100 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	2.7 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PROPANEDIOL (UNII: 5965N8W85T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHICONE (UNII: 92RU3N3Y1O)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
PSEUDANABAENA PERSICINA (UNII: ZA983U4810)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
TRIBEHENIN PEG-20 ESTERS (UNII: 84K9EH29Y9)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
CALCIUM CARBONATE (UNII: H0G9379FGK)
POLYSILICONE-15 (UNII: F8DRP5BB29)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70605-041-65	15 mL in 1 TUBE; Type 0: Not a Combination Product	05/31/2016
2	NDC: 70605-041-57	50 mL in 1 TUBE; Type 0: Not a Combination Product	05/31/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	05/31/2016

Labeler - Guthy-Renker LLC (948861877)