Proactiv Solution BB Cream Broad Spectrum SPF 15 (Light, Medium, Dark)

Proactiv Solution BB Broad Spectrum SPF 15 (Light, Medium, Dark) by

Drug Labeling and Warnings

Proactiv Solution BB Broad Spectrum SPF 15 (Light, Medium, Dark) by is a Otc medication manufactured, distributed, or labeled by Guthy-Renker LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PROACTIV SOLUTION BB BROAD SPECTRUM SPF 15 (LIGHT, MEDIUM, DARK)- octinoxate, octisalate, and oxybenzone lotion 
THE PROACTIV COMPANY LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Proactiv Solution BB Cream Broad Spectrum SPF 15 (Light, Medium, Dark)

Drug Facts

Active ingredients

Octinoxate 7.5%
Octisalate 5.0%
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 15 minutes before sun exposure
• reapply:
  • after 40 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
• 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
• children under 6 months: Ask a doctor

Inactive ingredients

water, ethylhexyl palmitate, isostearyl neopentanoate, propylene glycol, stearic acid, propylene glycol stearate SE, glycerin, talc, dimethicone, cetyl alcohol, magnesium ascorbyl phosphate, tocopherol, ascorbyl palmitate, sodium hyaluronate, lecithin, xanthan gum, sorbitan stearate, magnesium aluminum silicate, acrylates/C10-30 alkyl acrylate crosspolymer, ammonium polyacrylate, triethanolamine, disodium EDTA, phenoxyethanol, methylparaben, propylparaben, butylparaben, methylisothiazolinone. may contain (+/-) : iron oxides (CI 77491, CI 77492, CI 77499), titanium dioxide (CI 77891)

Other information

• protect this product from excessive heat and direct sun

Questions or comments?

Within US 1-800-950-4465

Dist. by: Guthy-Renker® LLC PO Box 14383
Palm Desert, CA 92255-4383

PRINCIPAL DISPLAY PANEL - 50 mL Tube Box

Rodan & Fields

proactiv®
SOLUTION

BB Cream

non-comedogenic
fragrance-free

BROAD SPECTRUM SPF 15

1.7 FL. OZ. 50 mL

PROACTIV SOLUTION BB BROAD SPECTRUM SPF 15 (LIGHT, MEDIUM, DARK) 
octinoxate, octisalate, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARIC ACID (UNII: 4ELV7Z65AP)
GLYCERIN (UNII: PDC6A3C0OX)
TALC (UNII: 7SEV7J4R1U)
DIMETHICONE (UNII: 92RU3N3Y1O)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
XANTHAN GUM (UNII: TTV12P4NEE)
CETYL ALCOHOL (UNII: 936JST6JCN)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
TROLAMINE (UNII: 9O3K93S3TK)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
PROPYLENE GLYCOL MONOPALMITOSTEARATE (UNII: F76354LMGR)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-001-17	1 in 1 BOX	12/01/2012	12/01/2019
1		50 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 FINAL	part352	12/01/2012	12/01/2019

Labeler - THE PROACTIV COMPANY LLC (080216357)

Revised: 12/2012

Document Id: facd4e2c-2622-44fa-afa2-fbd7a33daaa3

34390-5

Set id: ccdfa2f4-2e3c-443e-9981-699651870dc1

Version: 2

Effective Time: 20121213

 

THE PROACTIV COMPANY LLC