Locana Zinc Oxide Sunscreen Broad Spectrum SPF 40

Locana Zinc Oxide Sunscreen Broad Spectrum SPF 40 by

Drug Labeling and Warnings

Locana Zinc Oxide Sunscreen Broad Spectrum SPF 40 by is a Otc medication manufactured, distributed, or labeled by Wabis Tokyo Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LOCANA ZINC OXIDE SUNSCREEN BROAD SPECTRUM SPF 40- zinc oxide gel 
Wabis Tokyo Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Locana Zinc Oxide Sunscreen Broad Spectrum SPF 40

Drug Facts

Active ingredient

Zinc Oxide: 24.5%

Purpose

Sunscreen

Uses

• Helps prevent sun burn.
• 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

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

Directions

• Apply liberally 15 minutes before sun exposure.
• Sun Protection Measures. Spending time in the sun increases your r isk 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.
• Limit time in the sun, especially from 10 a.m. – 2 p.m.
• Wear long-sleeved shirts, pants, hats, and sunglasses.
• Reapply at least every 2 hours.
• Use a water resistant sunscreen if swimming or sweating.
• Children under 6 months of age: Ask a doctor.

Other information

• Protect the product in this container from excessive heat and direct sun.
• Store at 20–25°C (68–77°F)

Inactive ingredients

Water, Dimethicone, Caprylic/Capric Triglyceride, Polyhydroxystearic Acid, 1, 2-Hexanediol, Dimethicone /PEG-10/15 Crosspolymer, Hydrogen Dimethicone, Butylene Glycol, Tremella Fuciformis Polysaccharide, Aleurites Moluccanus Seed Oil, Rosa Roxburghii Fruit Extract, Geranium Rober tianum Extract, Terminalia Ferdinandiana Fruit Extract, Symphytum Officinale Leaf Extract, Allantoin, Morinda Citrifolia Fruit Juice, Myrciaria Dubia Fruit Extract, Ascorbyl Glucoside, Niacinamide, Thymus Serpyllum Extract, Hydrolyzed Prunus Domestica, Cynara Scolymus (Artichoke) Leaf Extract, Rosa Centifolia Flower Oil, Hibiscus Sabdariffa Flower Extract, Alpinia Speciosa Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Passiflora Edulis Fruit Extract, Plantago Major Seed Extract, Melissa Officinalis Leaf Extract, Glucosyl Hesperidin, Citrus Reticulata (Tangerine) Peel Extract, Glycine Soja (Soybean) Seed Extract, Scutellaria Baicalensis Root Extract, Xanthophylls, Vaccinium Myrtillus Leaf Extract, Cyanocoba lamin, Glucosyl Ceramide, Alpha-Glucan, Glycerin, Phytosterols, Hydrogenated Lecithin, Tocopherol, Zea Mays (Corn) Oil, Car thamus Tinctorius (Safflower) Seed Oil, Isostearic Acid, Sodium Chloride

Questions or comments?

Call 302-295-5078 Monday – Friday (9 a.m. – 5 p.m. CST)

Package Labeling:

LOCANA ZINC OXIDE SUNSCREEN BROAD SPECTRUM SPF 40 
zinc oxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81720-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	245 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
KUKUI NUT OIL (UNII: TP11QR7B8R)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
GERANIUM ROBERTIANUM WHOLE (UNII: R5I1HK0UBL)
KAKADU PLUM (UNII: 0ZQ1D2FDLI)
COMFREY LEAF (UNII: DG4F8T839X)
ALLANTOIN (UNII: 344S277G0Z)
NONI FRUIT JUICE (UNII: 6ULF85Z07J)
MYRCIARIA DUBIA FRUIT (UNII: YSW4EM1EKP)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
NIACINAMIDE (UNII: 25X51I8RD4)
THYMUS SERPYLLUM WHOLE (UNII: 86H4S6K51N)
CYNARA SCOLYMUS LEAF (UNII: B71UA545DE)
ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)
HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)
ALPINIA ZERUMBET LEAF (UNII: MS8P33AMKX)
CHAMOMILE (UNII: FGL3685T2X)
PASSIFLORA EDULIS FRUIT (UNII: 602YE42W5R)
PLANTAGO MAJOR SEED (UNII: YP0NFQ834U)
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)
GLUCOSYL HESPERIDIN (UNII: 432C95B6YE)
TANGERINE PEEL (UNII: JU3D414057)
SOYBEAN (UNII: L7HT8F1ZOD)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
LUTEIN (UNII: X72A60C9MT)
VACCINIUM MYRTILLUS LEAF (UNII: Y4U591OU70)
CYANOCOBALAMIN (UNII: P6YC3EG204)
SOYACEREBROSIDE I (UNII: OVF1RF8S49)
.ALPHA.-GLUCAN OLIGOSACCHARIDE (UNII: S95658MI3W)
GLYCERIN (UNII: PDC6A3C0OX)
PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
TOCOPHEROL (UNII: R0ZB2556P8)
CORN (UNII: 0N8672707O)
SAFFLOWER (UNII: 4VBL71TY4Y)
ISOSTEARIC ACID (UNII: X33R8U0062)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81720-100-01	1 in 1 BOX	04/01/2021	04/01/2021
1		40 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/01/2021	04/01/2021

Labeler - Wabis Tokyo Inc. (693258452)

Revised: 10/2021

Document Id: ce62de7d-9f29-8f33-e053-2a95a90a7dbc

34390-5

Set id: befd6f29-8bf8-fa1a-e053-2995a90af08d

Version: 2

Effective Time: 20211015