HAND SUNSCREEN CREAM- avobenzone, octisalate, octocrylene cream

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

Avobenzone - 3%
Octisalate - 5%
Octocrylene - 10%

PURPOSE

Sunscreen

INDICATIONS & USAGE

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

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 swallowed, get medical help or contact a Poison Control Center right away

DOSAGE & ADMINISTRATION

Apply generously and evenly 15 minutes before sun exposure.
Reapply: after 80 minutes of swimming or sweating, immediately after towel drying, at least every 2 hours
Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin agingTo 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: Ask a doctor.

INACTIVE INGREDIENT

Inactive Ingredients
Water, Glycerin, Butylocty, Salicylate, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Propanedtiol, Glyceryl StearateCitrate, Cocoglycerides, Isododecane, Cetyl Esters, CetylPhosphate, Diisopropyl Sebacate, IsodecylNeopentanoate, Lauryl, Lactate, Arginine, 1, 2-Hexanediol, Caprylyl Glycol, Hydroxyacetophenone,Polymethylsilsesquioxane, Raphanus Sativus (Radish) Seed Oil, Diethylhexyl Syingylidenemalonate, HelianthusAnnuus (Sunflower) Seed Wax, Limnanthes Alba(Meadowfoam) Seed Oil, Acrylates/C10-30 AlkylAcrylateCrosspolymer, Chlorphenesin, Xanthan Gum, Trisodium EthylenediamineDisuccinate, Argania Spinosa KernelOil, Caprylic/Capric Triglyceride, Citrus Nobilis (Mandarin Orange) Peel Oi, Plantago Lanceolata Leaf Extract,Glycine Soja(Soybean) Oil, Tocopherol, Cymbopogon Schoenanthus Oil, Hippopophae Rhamnoides Fruit Oil,ElettariaCardemomum Seed Oi, Eugenia Caryophyllus(Clove)Leaf Oil, Cinnamomum CassiaLeaf Oil, Vanillin,Eucalyptus Globulus Leaf Oil, Lavandula Hybrida Grosso Herb Oil
Other minor components
Butylene Glycol, Cetyl Alcohol Polyether-20, Stearoglycerin, EDTA Disodium, Ethylhexyl Stearate, Cactus Extract,Propylene Glycol, Xanthan Gum, Glycyrhza Root Extract, Oat Bran Extract, Hydroxy Kudzu Root Glycoside, PeonyRoot Extract, Kudzu Extract, Scutellaria Root Extract, Kudzu Glycoside

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HAND SUNSCREEN CREAM 
avobenzone, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85448-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.05 g  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.1 g  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.03 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ISODODECANE (UNII: A8289P68Y2)
GLYCERIN (UNII: PDC6A3C0OX)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
CITRUS NOBILIS (MANDARIN ORANGE) PEEL OIL (UNII: NJO720F72R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL BEHENATE (UNII: 2712V7RQMH)
SALICYLATE MEGLUMINE (UNII: Z1EQ13H492)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
CETYL ESTERS (UNII: D072FFP9GU)
DIETHANOLAMINE CETYL PHOSPHATE (UNII: 4UG0316V9S)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
LAURYL GLYCOL (UNII: EMM0U4H102)
ARGININE (UNII: 94ZLA3W45F)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX (UNII: 42DG15CHXV)
CYMBOPOGON SCHOENANTHUS OIL (UNII: XE7K568ILO)
EUGENIA CARYOPHYLLUS (CLOVE) LEAF OIL (UNII: VCA5491KVF)
SELENICEREUS GRANDIFLORUS FLOWER (UNII: II877K4UNR)
RAPHANUS SATIVUS VAR. SATIVUS SEED (UNII: A94I086Q5E)
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
GLYCINE MAX (SOYBEAN) OIL (UNII: 241ATL177A)
HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)
ELETTARIA CARDAMOMUM SEED OIL (UNII: JM0KJ091HZ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
LICORICE (UNII: 61ZBX54883)
PUERARIA MONTANA VAR. LOBATA ROOT (UNII: PET93F4I3C)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
EDETATE DISODIUM (UNII: 7FLD91C86K)
OAT BRAN (UNII: KQX236OK4U)
COCOGLYCERIDES (UNII: ISE9I7DNUG)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
CINNAMOMUM CASSIA LEAF OIL (UNII: 4U4V2F2E4Y)
EUCALYPTUS GLOBULUS LEAF OIL (UNII: 2R04ONI662)
GLYCERYL TRISTEARATE (UNII: P6OCJ2551R)
CETETH-20 (UNII: I835H2IHHX)
PLANTAGO LANCEOLATA LEAF (UNII: 2YWL9J7EE8)
3'-HYDROXYPUERARIN (UNII: M7KVR1LSN0)
POLYMETHYLSILSESQUIOXANE/TRIMETHYLSILOXYSILICATE (UNII: X2PZH4Y6HT)
ARGANIA SPINOSA KERNEL OIL (UNII: 4V59G5UW9X)
TOCOPHEROL (UNII: R0ZB2556P8)
VANILLIN (UNII: CHI530446X)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
LACTIC ACID (UNII: 33X04XA5AT)
LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL (UNII: ZBP1YXW0H8)
XANTHAN GUM (UNII: TTV12P4NEE)
LIMNANTHES ALBA (MEADOWFOAM) SEED OIL (UNII: 412ZHA4T4Y)
CHLORPHENESIN (UNII: I670DAL4SZ)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85448-002-01	44 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/01/2026

Labeler - Jiangsu Senwo Medical Technology Co., Ltd. (569521612)

Establishment
Name	Address	ID/FEI	Business Operations
Jiangsu Senwo Medical Technology Co., Ltd.		569521612	manufacture(85448-002)