EVE LOM FLAWLESS RADIANCE PRIMER BROAD SPECTRUM SPF 30 SUNSCREEN- octinoxate, octisalate, octocrylene, oxybenzone and avobenzone lotion

Eve Lom Flawless Radiance Primer Broad Spectrum SPF 30 Sunscreen by

Drug Labeling and Warnings

Eve Lom Flawless Radiance Primer Broad Spectrum SPF 30 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Space Brands Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

PURPOSE

Active Ingredients           Purpose

Octinoxate 6.7%                Sunscreen

Octisalate 4.5%                 Sunscreen

Octocrylene 4.5%              Sunscreen

Oxybenzone 3%                Sunscreen

Avobenzone 2.7%             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

Do not use on damaged or broken skin

WHEN USING

When using this product keep out of eyes. Rinse with water to remove.

STOP USE

Stop use and ask a doctor if rash occurs.

KEEP OUT OF REACH OF CHILDREN

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
• children under 6 months of age: Ask a doctor
• 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 of 15 of 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, glycerin, ethylhexyl methoxycrylene, cetearyl alcohol, niacinamide, dimethicone, nylon-12, glyceryl stearate, vp/eicosene copolymer, phenoxyethanol, caprylic/capric triglyceride, potassium behenoyl hydroxyproline, polysilicone-11, ethylhexylhlycerin, sodium carbomer, chlorphenesin, xanthan gum, mica, tocopheryl acetate, behenic acid, disodium edta, squalane, sodium hyaluronate, pancratium maritimum extract, rosa centifolia flower extract, rubus idaeus leaf cell culture, titanium dioxide (CI 77891).

Other information

• protect this product from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL - 50 mL CARTONEVE LOMFLAWLESS RADIANCE PRIMERBROAD SPECTRUM SPF 30 SUNSCREEN50 mL 1.7 FL. OZ e

INGREDIENTS AND APPEARANCE

EVE LOM FLAWLESS RADIANCE PRIMER BROAD SPECTRUM SPF 30 SUNSCREEN 
octinoxate, octisalate, octocrylene, oxybenzone and avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61601-1250
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.35 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.25 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.25 g  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	1.50 g  in 50 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.35 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
NIACINAMIDE (UNII: 25X51I8RD4)
DIMETHICONE (UNII: 92RU3N3Y1O)
NYLON-12 (UNII: 446U8J075B)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POTASSIUM BEHENOYL HYDROXYPROLINE (UNII: 82EPB0Q5XG)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CHLORPHENESIN (UNII: I670DAL4SZ)
XANTHAN GUM (UNII: TTV12P4NEE)
MICA (UNII: V8A1AW0880)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BEHENIC ACID (UNII: H390488X0A)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SQUALANE (UNII: GW89575KF9)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ROSA CENTIFOLIA FLOWER (UNII: CS4TE8FF7O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61601-1250-3	1 in 1 CARTON
1		50 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/01/2014

Labeler - Space Brands Limited (218214381)