Drug labels

REPAIRWEAR UPLIFTING FIRMING BROAD SPECTUM SPF 15 - NORMAL COMBO TO COMBINATION oily

OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE · CLINIQUE LABORATORIES LLC · TOPICAL

HUMAN OTC DRUG
Open FDA's page for this record
Set ID
10edc0c1-9359-4c7a-a56e-bad06fea0056
ID
2e9b7724-d4e9-a6d1-e063-6294a90ab9c9
Effective time
20250220
Version
10
SPL product data elements

REPAIRWEAR UPLIFTING FIRMING BROAD SPECTUM SPF 15 - NORMAL COMBO TO COMBINATION oily OCTINOXATE, OCTISALATE, and TITANIUM DIOXIDE SODIUM LACTATE HYDROGENATED SOYBEAN LECITHIN WHEY METHICONE (20 CST) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) EDETATE DISODIUM ANHYDROUS WATER NEOPENTYL GLYCOL DIHEPTANOATE JOJOBA BUTTER GLYCERIN PETROLATUM OCTYLDODECYL NEOPENTANOATE DI-C12-15 ALKYL FUMARATE DIMETHICONE BUTYLENE GLYCOL HEXYLDECYL STEARATE CLARY SAGE CHLORELLA VULGARIS LITCHI CHINENSIS SEED LAMINARIA DIGITATA CLADOSIPHON OKAMURANUS ASTROCARYUM MURUMURU SEED BUTTER ACETYL HEXAPEPTIDE-8 PENTYLENE GLYCOL ERGOTHIONEINE GLYCERYL MONOSTEARATE CAFFEINE SORBITOL DOCOSANOL HYALURONATE SODIUM .ALPHA.-TOCOPHEROL ACETATE PEG-100 STEARATE PENTAERYTHRITYL TETRAETHYLHEXANOATE CAPRYLYL GLYCOL C12-16 ALCOHOLS CHOLESTEROL ICODEXTRIN PALMITIC ACID TETRAHEXYLDECYL ASCORBATE HEXYLENE GLYCOL CITRIC ACID MONOHYDRATE XANTHAN GUM AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER SODIUM HYDROXIDE POTASSIUM SORBATE PHENOXYETHANOL FD&C RED NO. 4 FD&C YELLOW NO. 5 MICA OCTINOXATE OCTINOXATE OCTISALATE OCTISALATE TITANIUM DIOXIDE TITANIUM DIOXIDE HYDROGENATED POLYBUTENE (1300 MW) STARCH, POTATO SIGESBECKIA ORIENTALIS FLOWERING TOP LECITHIN, SOYBEAN SYNTHETIC WAX (1200 MW) BHT ALUMINUM HYDROXIDE CHLORPHENESIN

SPL unclassified section
Drug Facts, DIST. N.Y., N.Y. 10022
Active ingredient
Active ingredients Octinoxate 7.5% Octisalate 3.5% Titanium dioxide 1.7%
Purpose
Purpose Sunscreen
Indications and usage
Use helps prevent sunburn
Warnings

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.

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 product is swallowed, get medical help or contact a Poison Control Center right away.
Dosage and administration

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 ingredient

Inactive ingredients water\aqua\eau,neopentyl glycol diheptanoate,simmondsia chinensis (jojoba) butter,glycerin,petrolatum,octyldodecyl neopentanoate,di-c12-15 alkyl fumarate,dimethicone,hydrogenated lecithin,butylene glycol,hexyldecyl stearate,hydrogenated polyisobutene,synthetic wax,whey protein\lactis protein\protéine du petit-lait,sigesbeckia orientalis (st. paul's wort) extract,salvia sclarea (clary) extract,chlorella vulgaris extract,litchi chinensis seed extract,laminaria digitata extract,cladosiphon okamuranus extract,plankton extract,astrocaryum murumuru seed butter,acetyl hexapeptide-8,lecithin,pentylene glycol,potato starch modified,ergothioneine,glyceryl stearate,caffeine,sorbitol,behenyl alcohol,sodium hyaluronate,tocopheryl acetate,peg-100 stearate,pentaerythrityl tetraethylhexanoate,caprylyl glycol,c12-16 alcohols,cholesterol,polysilicone-11,dextrin,palmitic acid,tetrahexyldecyl ascorbate,hexylene glycol,aluminum hydroxide,methicone,citric acid,xanthan gum,ammonium acryloyldimethyltaurate/vp copolymer,sodium hydroxide,disodium edta,potassium sorbate,phenoxyethanol,sodium lactate,chlorphenesin,bht,mica,titanium dioxide (ci 77891),red 4 (ci 14700),yellow 5 (ci 19140) <iln51403>

Storage and handling
Other information protect the product in this container from excessive heat and direct sun
Package label principal display panel

PRINCIPAL DISPLAY PANEL - 50 mL Jar Carton C CLINIQUE repairwear uplifting firming cream broad spectrum SPF 15 DRY COMBINATION TO COMBINATION OILY POIDS NET WT. 1.7. OZ./50 ml e PDP

Harmonized identifiers (openFDA)
Application number
M020
Brand name
REPAIRWEAR UPLIFTING FIRMING BROAD SPECTUM SPF 15 - NORMAL COMBO TO COMBINATION oily
Generic name
OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE
Manufacturer name
CLINIQUE LABORATORIES LLC
Product NDC
49527-022
Product type
HUMAN OTC DRUG
Route
TOPICAL
Substance name
OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE
SPL ID
2e9b7724-d4e9-a6d1-e063-6294a90ab9c9
SPL set ID
10edc0c1-9359-4c7a-a56e-bad06fea0056
Package NDC
49527-022-01
Is original packager
true
UNII
4Y5P7MUD51, 4X49Y0596W, 15FIX9V2JP
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.