Drug labels

REPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY

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

HUMAN OTC DRUG
Open FDA's page for this record
Set ID
07701e11-8a7e-44c5-b46e-5b48264eacad
ID
32c42bda-e70e-fc0b-e063-6394a90a8614
Effective time
20250414
Version
10
SPL product data elements

REPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY OCTINOXATE, OCTISALATE, and TITANIUM DIOXIDE WATER PETROLATUM HIGH DENSITY POLYETHYLENE GLYCERIN OCTYLDODECYL NEOPENTANOATE DI-C12-15 ALKYL FUMARATE DIMETHICONE BUTYLENE GLYCOL HEXYLDECYL STEARATE GLYCERYL MONOSTEARATE PENTYLENE GLYCOL CLARY SAGE CHLORELLA VULGARIS GUGGUL LITCHI CHINENSIS SEED LAMINARIA DIGITATA CLADOSIPHON OKAMURANUS ASTROCARYUM MURUMURU SEED BUTTER SORBITOL CAFFEINE CHOLESTEROL ACETYL HEXAPEPTIDE-8 HYALURONATE SODIUM PEG-100 STEARATE PENTAERYTHRITYL TETRAETHYLHEXANOATE DOCOSANOL .ALPHA.-TOCOPHEROL ACETATE CAPRYLYL GLYCOL C12-16 ALCOHOLS MEDIUM-CHAIN TRIGLYCERIDES ERGOTHIONEINE ICODEXTRIN PALMITIC ACID AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER TETRAHEXYLDECYL ASCORBATE HEXYLENE GLYCOL CITRIC ACID MONOHYDRATE POTASSIUM SORBATE XANTHAN GUM ALUMINUM OXIDE SODIUM HYDROXIDE EDETATE DISODIUM PHENOXYETHANOL FD&C RED NO. 4 FD&C YELLOW NO. 5 MICA OCTINOXATE OCTINOXATE OCTISALATE OCTISALATE TITANIUM DIOXIDE TITANIUM DIOXIDE

SPL unclassified section
Drug Facts
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
For external use only 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 • simmondsia chinensis (jojoba) butter • petrolatum • polyethylene • glycerin • octyldodecyl neopentanoate • di-c12-15 alkyl fumarate • dimethicone • hydrogenated lecithin • butylene glycol • hydrogenated polyisobutene • hexyldecyl stearate • glyceryl stearate • pentylene glycol • potato starch modified • sigesbeckia orientalis (st. paul's wort) extract • salvia sclarea (clary) extract • chlorella vulgaris extract • commiphora mukul resin extract • litchi chinensis seed extract • laminaria digitata extract • plankton extract • cladosiphon okamuranus extract • whey protein\lactis protein\protéine du petit-lait • astrocaryum murumuru seed butter • sorbitol • caffeine • cholesterol • lecithin • acetyl hexapeptide-8 • sodium hyaluronate • peg-100 stearate • pentaerythrityl tetraethylhexanoate • behenyl alcohol • tocopheryl acetate • caprylyl glycol • c12-16 alcohols • caprylic/capric triglyceride • ergothioneine • polysilicone-11 • methicone • dextrin • palmitic acid • ammonium acryloyldimethyltaurate/vp copolymer • tetrahexyldecyl ascorbate • hexylene glycol • citric acid • potassium sorbate • xanthan gum • alumina • sodium hydroxide • disodium edta • phenoxyethanol • red 4 (ci 14700) • yellow 5 (ci 19140) • titanium dioxide (ci 77891) • mica [iln39282]

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 CLINIQUE repairwear uplifting firming cream broad spectrum SPF 15 VERY DRY TO DRY POIDS NET WT. 1.7 OZ./50 ml e Folding Carton

Harmonized identifiers (openFDA)
Application number
M020
Brand name
REPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY
Generic name
OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE
Manufacturer name
CLINIQUE LABORATORIES LLC
Product NDC
49527-017
Product type
HUMAN OTC DRUG
Route
TOPICAL
Substance name
OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE
SPL ID
32c42bda-e70e-fc0b-e063-6394a90a8614
SPL set ID
07701e11-8a7e-44c5-b46e-5b48264eacad
Package NDC
49527-017-01
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.