Dermablend Professional Leg and Body Makeup Broad Spectrum SPF 25 Sunscreen: Package Insert and Label Information

DERMABLEND PROFESSIONAL LEG AND BODY MAKEUP BROAD SPECTRUM SPF 25 SUNSCREEN- octisalate and octocrylene lotion
L’Oreal USA Products Inc

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.

Active ingredients

Octisalate 3.2%

Octocrylene 6%

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 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 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

Inactive ingredients

water, cyclopentasiloxane, isododecane, isononyl isononanoate, glycerin, cetyl PEG/PPG-10/1 dimethicone, dimethicone, magnesium sulfate, polyglyceryl-4 isostearate, dimethicone/PEG-10/15 crosspolymer, disodium stearoyl glutamate, disteardimonium hectorite, phenoxyethanol, polybutene, methylparaben, alcohol denat., chlorphenesin, acrylonitrile/methyl methacrylate/vinylidene chloride copolymer, butylparaben, aluminum hydroxide, sodium hydroxide, isobutane, dipropylene glycol, sodium citrate, tocopherol, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate; may contain: titanium dioxide, iron oxides

Questions or comments?

1-877-900-6700

Monday — Friday (9 a.m. — 5 p.m. EST)

image of a label
(click image for full-size original)

DERMABLEND PROFESSIONAL LEG AND BODY MAKEUP BROAD SPECTRUM SPF 25 SUNSCREEN
octisalate and octocrylene lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-906
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTISALATE (OCTISALATE) OCTISALATE 32 mg in 1 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 60 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
CYCLOMETHICONE 5
ISODODECANE
ISONONYL ISONONANOATE
GLYCERIN
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5)
DIMETHICONE
MAGNESIUM SULFATE, UNSPECIFIED FORM
POLYGLYCERYL-4 ISOSTEARATE
DISODIUM STEAROYL GLUTAMATE
DISTEARDIMONIUM HECTORITE
PHENOXYETHANOL
POLYBUTENE (1400 MW)
METHYLPARABEN
ALCOHOL
CHLORPHENESIN
BUTYLPARABEN
ALUMINUM HYDROXIDE
HYALURONATE SODIUM
ISOBUTANE
DIPROPYLENE GLYCOL
SODIUM CITRATE
TOCOPHEROL
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)
TITANIUM DIOXIDE
FERRIC OXIDE RED
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49967-906-01 1 TUBE in 1 CARTON contains a TUBE
1 100 mL in 1 TUBE This package is contained within the CARTON (49967-906-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 01/01/2017
Labeler — L’Oreal USA Products Inc (002136794)
Establishment
Name Address ID/FEI Operations
Cosmax USA, Inc. 010990210 manufacture (49967-906)
Establishment
Name Address ID/FEI Operations
L’Oreal, USA, Inc. 185931458 manufacture (49967-906)

Revised: 01/2020 L’Oreal USA Products Inc

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2020. All Rights Reserved.