Drug labels

Advanced Sun Resistance SPF 30

HOMOSALATE, OCTINOXATE, OXYBENZONE, OCTISALATE, AVOBENZONE · June Jacobs Labs, LLC · TOPICAL

HUMAN OTC DRUG
Open FDA's page for this record
Set ID
18f879f0-3d5b-0067-e063-6394a90a9db3
ID
18f879f0-3d5c-0067-e063-6394a90a9db3
Effective time
20240521
Version
1
SPL product data elements

Advanced Sun Resistance SPF 30 Homosalate, Octinoxate, Oxybenzone, Octisalate, Avobenzone AVOBENZONE AVOBENZONE LEMON OIL LAVANDIN OIL ROSA CANINA SEED LYCIUM BARBARUM FRUIT CHONDRUS CRISPUS CARRAGEENAN FUCUS VESICULOSUS WATER TROLAMINE ASPALATHUS LINEARIS LEAF ASIAN GINSENG SOYBEAN LECITHIN .ALPHA.-TOCOPHEROL ACETATE ASCORBIC ACID OXYBENZONE OXYBENZONE CHOLECALCIFEROL OCTINOXATE OCTINOXATE PUNICA GRANATUM ROOT BARK VITIS VINIFERA SEED ALOE VERA LEAF POGOSTEMON CABLIN LEAF OIL PUMMELO PEG-100 STEARATE HOMOSALATE HOMOSALATE PROPYLENE GLYCOL ALLANTOIN MANDARIN OIL LIME PEEL PYRIDOXINE DIMETHICONE GLYCERIN CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE JUNIPERUS VIRGINIANA OIL LITSEA OIL OCTISALATE OCTISALATE GLYCERYL MONOSTEARATE STEARIC ACID ALKYL (C12-15) BENZOATE MEDIUM-CHAIN TRIGLYCERIDES CAPRYLYL GLYCOL GRAPEFRUIT OIL GREEN TEA LEAF PHENOXYETHANOL LIMONENE, (+)- ACAI CRANBERRY CAPRYLHYDROXAMIC ACID CITRONELLA OIL ORANGE OIL PANTHENOL CETYL ALCOHOL SIMMONDSIA CHINENSIS LEAF MALTODEXTRIN VITAMIN A PALMITATE ASCORBYL PALMITATE CITRAL LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE POMEGRANATE White to off white

Active ingredient
Active ingredients Homosalate 10.00% Octinoxate 7.50% Oxybenzone 6.00% Octisalate 5.00% Avobenzone 3.00%
Purpose
Sunscreen
Indications and usage

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
Warnings For external use only
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

■ Apply liberally and evenly 15 minutes before sun exposure ■ Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with 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 ■ Reapply at least every 2 hours ■ Use a water resistant sunscreen if swim ming or sweating ■ Children under 6 months: Ask a doctor

Inactive ingredient

Inactive ingredients Water/Aqua/Eau, Propylene Glycol, Glyceryl Stearate, PEG-100 Stearate , Stearic Acid, Citrus Aurantium Dulcis (Orange) Peel Oil, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Dimethicone, Caprylyl Glycol, Glycerin, Carbomer, Allantoin, Citrus Paradisi (Grapefruit) Peel Oil, Caprylhydroxamic Acid, Panthenol, Cetyl Alcohol, Triethanolamine, Citrus Nobilis (Mandarin Orange) Peel Oil, Lycium Barbarum Fruit Extract , Punica Granatum Extract, Vitis Vinifera (Grape) Seed Extract, Aspalathus Linearis Leaf Extract , Aloe Barbadensis Leaf Juice, Citrus Limon (Lemon) Peel Oil, Pogostemon Cablin Oil, Citrus Aurantifolia (Lime) Peel Oil, Juniperus Virginiana Wood Oil, Litsea Cubeba Fruit Oil, Cymbopogon Nardus (Citronella) Oil, Lavandula Hybrida Oil, Citrus Grandis (Grapefruit) Fruit Extract, Panax Ginseng Root Extract, Rosa Canina Seed Extract, Chondrus Crispus Extract, Fucus Vesiculosus Extract, Simmondsia Chinensis (Jojoba) Leaf Extract, Leuconostoc/Radish Root Ferment Filtrate, Phospholipids, Maltodextrin, Camellia Sinensis Leaf Extract, Tocopheryl Acetate, Phenoxyethanol, Retinyl Palmitate, Ascorbyl Palmitate, Euterpe Oleracea Fruit Extract, Punica Granatum Fruit Extract, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Cholecalciferol , Ascobic Acid, Pyridoxine, Limonene, Citral

Other safety information
Other information ■ Protect this product from excessive heat and direct sun
Questions
Questions or comments? Call toll free 1-866-JUNEJACOBS
Package label principal display panel
ADVSunSPF30 Carton ADVSunSPF30 Tube
Harmonized identifiers (openFDA)
Application number
M020
Brand name
Advanced Sun Resistance SPF 30
Generic name
HOMOSALATE, OCTINOXATE, OXYBENZONE, OCTISALATE, AVOBENZONE
Manufacturer name
June Jacobs Labs, LLC
Product NDC
65278-319
Product type
HUMAN OTC DRUG
Route
TOPICAL
Substance name
AVOBENZONE, OXYBENZONE, OCTINOXATE, HOMOSALATE, OCTISALATE
SPL ID
18f879f0-3d5c-0067-e063-6394a90a9db3
SPL set ID
18f879f0-3d5b-0067-e063-6394a90a9db3
Package NDC
65278-319-01, 65278-319-02
Is original packager
true
UNII
G63QQF2NOX, 95OOS7VE0Y, 4Y5P7MUD51, V06SV4M95S, 4X49Y0596W
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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.