PRIMER PLUS RADIANCE BROAD SPECTRUM SPF 35- octinoxate, octisalate, oxybenzone, titanium dioxide, and zinc oxide cream

PRIMER PLUS RADIANCE BROAD SPECTRUM SPF 35 by

Drug Labeling and Warnings

PRIMER PLUS RADIANCE BROAD SPECTRUM SPF 35 by is a Otc medication manufactured, distributed, or labeled by Bobbi Brown Professional Cosmetics Inc., Estee Lauder Companies Inc., PALC, Estee Lauder Cosmetics Ltd., Northtec LLC, PADC 1, Len-Ron Manufacturing Division of Aramis Inc., Whitman Laboratories Ltd., Estee Lauder N.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Octinoxate 7.50%
Octisalate 4.00%
Oxybenzone 2.50%
Titanium Dioxide 1.10%
Zinc Oxide 3.30%

Purpose

Sunscreen

Use

Helps prevent sunburn

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

For sunscreen use:

• apply liberally 15 minutes before sun exposure
• reapply at least every two 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

Inactive ingredients

water\aqua\eau ◾ dimethicone ◾ butylene glycol ◾ phenyl trimethicone ◾ pentylene glycol ◾ glyceryl stearate ◾ behenyl alcohol ◾ trioctyldodecyl citrate ◾ polymethylsilsesquioxane ◾ octyldodecyl stearoyl stearate ◾ peg-40 stearate ◾ polyglyceryl-10 pentastearate ◾ pyrus malus (apple) fruit extract ◾ laminaria saccharina extract ◾ cucumis sativus (cucumber) fruit extract ◾ triticum vulgare (wheat) germ extract ◾ acetyl hexapeptide-8 ◾ scutellaria baicalensis root extract ◾ hordeum vulgare (barley) extract\extrait d'orge ◾ polyquaternium-51 ◾ oryzanol ◾ glycyrrhetinic acid ◾ octyldodecyl neopentanoate ◾ trehalose ◾ propylene glycol laurate ◾ sucrose ◾ glycerin ◾ cholesterol ◾ caffeine ◾ sodium hyaluronate ◾ linoleic acid ◾ lecithin ◾ squalane ◾ propylene glycol stearate ◾ urea ◾ ammonium acryloyldimethyltaurate/vp copolymer ◾ polyglyceryl-6 polyricinoleate ◾ polysorbate 20 ◾ tocopheryl acetate ◾ sodium stearoyl lactylate ◾ stearic acid ◾ sorbitan laurate ◾ xanthan gum ◾ alumina ◾ sodium pca ◾ isopropyl titanium triisostearate ◾ sodium dehydroacetate ◾ triethoxycaprylylsilane ◾ disodium edta ◾ silica ◾ chlorphenesin ◾ phenoxyethanol ◾ [+/- mica ◾ ferric ferrocyanide (ci 77510) ◾ ferric ammonium ferrocyanide (ci 77510) ◾ chromium hydroxide green (ci 77289) ◾ chromium oxide greens (ci 77288) ◾ carmine (ci 75470) ◾ titanium dioxide (ci 77891) ◾ iron oxides (ci 77491) ◾ iron oxides (ci 77492) ◾ iron oxides (ci 77499) ◾ yellow 5 lake (ci 19140) ◾ blue 1 lake (ci 42090)] <iln40231>

Other information

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

PRINCIPAL DISPLAY PANEL - 40 ml Container Carton

BOBBI
BROWN

Primer Plus
Radiance
Broad Spectrum
SPF 35

1.4 FL. OZ./40 ml e

INGREDIENTS AND APPEARANCE

PRIMER PLUS RADIANCE BROAD SPECTRUM SPF 35 
octinoxate, octisalate, oxybenzone, titanium dioxide, and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64141-029
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.08625 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.046 g  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.02875 g  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.01265 g  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.0391 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
dimethicone (UNII: 92RU3N3Y1O)
butylene glycol (UNII: 3XUS85K0RA)
phenyl trimethicone (UNII: DR0K5NOJ4R)
pentylene glycol (UNII: 50C1307PZG)
glyceryl monostearate (UNII: 230OU9XXE4)
docosanol (UNII: 9G1OE216XY)
trioctyldodecyl citrate (UNII: 35X8CT063R)
polymethylsilsesquioxane (4.5 microns) (UNII: 59Z907ZB69)
octyldodecyl stearoyl stearate (UNII: 3D47Q6D93C)
peg-40 stearate (UNII: ECU18C66Q7)
polyglyceryl-10 pentastearate (UNII: PMX5872701)
apple (UNII: B423VGH5S9)
cucumber (UNII: YY7C30VXJT)
wheat (UNII: 4J2I0SN84Y)
acetyl hexapeptide-8 (UNII: L4EL31FWIL)
scutellaria baicalensis root (UNII: 7J95K7ID2S)
barley (UNII: 5PWM7YLI7R)
gamma oryzanol (UNII: SST9XCL51M)
enoxolone (UNII: P540XA09DR)
octyldodecyl neopentanoate (UNII: X8725R883T)
trehalose (UNII: B8WCK70T7I)
propylene glycol monolaurate (UNII: 668Z5835Z3)
sucrose (UNII: C151H8M554)
glycerin (UNII: PDC6A3C0OX)
cholesterol (UNII: 97C5T2UQ7J)
caffeine (UNII: 3G6A5W338E)
hyaluronate sodium (UNII: YSE9PPT4TH)
linoleic acid (UNII: 9KJL21T0QJ)
squalane (UNII: GW89575KF9)
propylene glycol monostearate (UNII: MZM1I680W0)
urea (UNII: 8W8T17847W)
ammonium acryloyldimethyltaurate/vp copolymer (UNII: W59H9296ZG)
polysorbate 20 (UNII: 7T1F30V5YH)
sodium stearoyl lactylate (UNII: IN99IT31LN)
stearic acid (UNII: 4ELV7Z65AP)
sorbitan monolaurate (UNII: 6W9PS8B71J)
xanthan gum (UNII: TTV12P4NEE)
aluminum oxide (UNII: LMI26O6933)
sodium pyrrolidone carboxylate (UNII: 469OTG57A2)
isopropyl titanium triisostearate (UNII: 949E3KBJ1I)
sodium dehydroacetate (UNII: 8W46YN971G)
triethoxycaprylylsilane (UNII: LDC331P08E)
edetate disodium anhydrous (UNII: 8NLQ36F6MM)
silicon dioxide (UNII: ETJ7Z6XBU4)
chlorphenesin (UNII: I670DAL4SZ)
phenoxyethanol (UNII: HIE492ZZ3T)
mica (UNII: V8A1AW0880)
ferric ferrocyanide (UNII: TLE294X33A)
ferric ammonium ferrocyanide (UNII: 9R0NVI936I)
chromium hydroxide green (UNII: RV8FT8XF5R)
chromic oxide (UNII: X5Z09SU859)
carminic acid (UNII: CID8Z8N95N)
ferric oxide red (UNII: 1K09F3G675)
ferric oxide yellow (UNII: EX438O2MRT)
ferrosoferric oxide (UNII: XM0M87F357)
fd&c yellow no. 5 (UNII: I753WB2F1M)
fd&c blue no. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64141-029-01	1 in 1 CARTON	02/01/2019
1		40 mL in 1 CONTAINER; 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	02/01/2019

Labeler - Bobbi Brown Professional Cosmetics Inc. (627131279)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(64141-029) , REPACK(64141-029)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(64141-029)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(64141-029)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(64141-029)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(64141-029)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(64141-029) , REPACK(64141-029)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(64141-029) , REPACK(64141-029)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(64141-029)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(64141-029)