TOLERIANE DOUBLE REPAIR MOISTURIZER UV SPF 30- avobenzone, homosalate, octisalate, octocrylene cream

Toleriane Double Repair Moisturizer UV SPF 30 by

Drug Labeling and Warnings

Toleriane Double Repair Moisturizer UV SPF 30 by is a Otc medication manufactured, distributed, or labeled by BPS 60. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Avobenzone 3%

Homosalate 5%

Octisalate 5%

Octocrylene 7%

Purpose

Sunscreen

Use

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

Directions

For sunscreen use:

● apply generously 15 minutes before sun exposure

● reapply at leasst 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 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

Other information

• protect the product in this container from excessive heat and direct sun
• store at 20° - 25° C 968° to 77° F)

Inactive ingredients

water, glycerin, silica, dimethicone, niacinamide, PEG-100 stearate, glyceryl stearate, stearic acid, allantoin, ceramide NP, dimethicone/vinyl dimethicone crosspolymer, sodium hydroxide, myristic acid, palmitic acid, ammonium polyacryloyldimethyl taurate, disodium EDTA, capryloyl glycine, caprylyl glycol, citric acid, xanthan gum, t-butyl alcohol, cetyl alcohol, tocopherol

Questions or comments?

1-88-LRP-LABO 1-800-577-5226 Monday - Friday (9 a.m. - 5 p.m. EST)

Package Labeling:

INGREDIENTS AND APPEARANCE

TOLERIANE DOUBLE REPAIR MOISTURIZER UV SPF 30 
avobenzone, homosalate, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70581-017
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	50 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	70 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
CETYL ALCOHOL (UNII: 936JST6JCN)
TOCOPHEROL (UNII: R0ZB2556P8)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIMETHICONE (UNII: 92RU3N3Y1O)
NIACINAMIDE (UNII: 25X51I8RD4)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALLANTOIN (UNII: 344S277G0Z)
CERAMIDE NP (UNII: 4370DF050B)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
MYRISTIC ACID (UNII: 0I3V7S25AW)
PALMITIC ACID (UNII: 2V16EO95H1)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70581-017-00	1 in 1 BOX	12/26/2017
1		75 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 not final	part352	12/26/2017

Labeler - BPS 60 (272259304)