ADVANCED SUN RESISTANCE SPF 30- homosalate, octinoxate, oxybenzone, octisalate, avobenzone cream

Advanced Sun Resistance SPF 30 by

Drug Labeling and Warnings

Advanced Sun Resistance SPF 30 by is a Otc medication manufactured, distributed, or labeled by June Jacobs Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Homosalate 10.00%

Octinoxate 7.50%

Oxybenzone 6.00%

Octisalate 5.00%

Avobenzone 3.00%

PURPOSE

Sunscreen

INDICATIONS & 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 & 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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ADVANCED SUN RESISTANCE SPF 30 
homosalate, octinoxate, oxybenzone, octisalate, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65278-319
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3.371 g  in 112.38 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	6.743 g  in 112.38 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	8.429 g  in 112.38 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	11.238 g  in 112.38 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5.619 g  in 112.38 g

Inactive Ingredients
Ingredient Name	Strength
LEMON OIL (UNII: I9GRO824LL)
LAVANDIN OIL (UNII: 9RES347CKG)
ROSA CANINA SEED (UNII: 4503R1M9UT)
LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)
CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)
FUCUS VESICULOSUS (UNII: 535G2ABX9M)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)
ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)
ASIAN GINSENG (UNII: CUQ3A77YXI)
SOYBEAN LECITHIN (UNII: 1DI56QDM62)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)
VITIS VINIFERA SEED (UNII: C34U15ICXA)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
POGOSTEMON CABLIN LEAF OIL (UNII: F3IN55X5PO)
PUMMELO (UNII: ET1TN5W71X)
PEG-100 STEARATE (UNII: YD01N1999R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALLANTOIN (UNII: 344S277G0Z)
MANDARIN OIL (UNII: NJO720F72R)
LIME PEEL (UNII: 544EQK5Q0W)
PYRIDOXINE (UNII: KV2JZ1BI6Z)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
JUNIPERUS VIRGINIANA OIL (UNII: PAD4FN7P2G)
LITSEA OIL (UNII: 2XIW34BN6O)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GRAPEFRUIT OIL (UNII: YR377U58W9)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
ACAI (UNII: 46AM2VJ0AW)
CRANBERRY (UNII: 0MVO31Q3QS)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CITRONELLA OIL (UNII: QYO8Q067D0)
ORANGE OIL (UNII: AKN3KSD11B)
PANTHENOL (UNII: WV9CM0O67Z)
CETYL ALCOHOL (UNII: 936JST6JCN)
SIMMONDSIA CHINENSIS LEAF (UNII: 67G221EK95)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CITRAL (UNII: T7EU0O9VPP)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
POMEGRANATE (UNII: 56687D1Z4D)

Product Characteristics
Color	white (White to off white)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65278-319-01	112.38 g in 1 TUBE; Type 0: Not a Combination Product	03/20/2021
2	NDC: 65278-319-02	112.38 g in 1 CARTON; Type 0: Not a Combination Product	03/20/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/20/2021

Labeler - June Jacobs Labs, LLC (082439410)

Establishment
Name	Address	ID/FEI	Business Operations
June Jacobs Labs, LLC		122610681	manufacture(65278-319)