DEWY SKIN FACE- zinc oxide lotion

Dewy Skin Face by

Drug Labeling and Warnings

Dewy Skin Face by is a Otc medication manufactured, distributed, or labeled by The Seaweed Bath Co., Sun Deep Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Zinc Oxide 20.8%

Purpose

Sunscreen

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

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 and evenly as the last step in your skin care routine and 15 minutes before sun exposure. Wear alone or under makeup
• 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.

Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Aqua/Water/Eau with Fucus Vesiculosus (Bladderwrack Seaweed) and Chlorella Vulgaris (Algae) Extracts, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Polyglyceryl-6 Distearate, Glycerin, Betaine, Glyceryl Stearate, Sorbitan Sesquioleate, Caprylhydroxamic Acid, Glyceryl Caprylate, Diheptyl Succinate, Capryloyl Glycerin/Sebacic Acid Copolymer, Natural Fragrance, Polyhydroxystearic Acid, Squalane, Niacinamide, Sodium Hyaluronate, Red Algae (Gigartina Skottsbergii) Extract, Sodium PCA, Tocopheryl Acetate (Vitamin E), Xanthan Gum, Tetrahexyldecyl Ascorbate (Vitamin C), Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Sambucus Nigra (Black Elderberry) Fruit Extract, Citric Acid, Juniperus Communis Fruit Extract, Allantoin, Frangula Alnus Bark (Buckthorn) Extract, Bisabolol, Ocimum Basilicum (Basil) Flower/Leaf Extract, Sodium Stearoyl Glutamate, Betula Alba (Birch) Leaf Extract, Tocopheryl (Vitamin E).

Questions?

Call toll free 1-877-317-3106

PRINCIPAL DISPLAY PANEL - 59 mL Bottle Carton

SEAWEED®
BATH CO.

mineral
SPF

hydrate & protect

DEWY
SKIN
FACE
LOTION

with squalane
& hyaluronic acid

SPF 30
SUNSCREEN

SEA MAGIC

Broad Spectrum SPF 30

2.0 fl oz (59 mL)

INGREDIENTS AND APPEARANCE

DEWY SKIN FACE 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81159-387
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	20.8 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
FUCUS VESICULOSUS (UNII: 535G2ABX9M)
CHLORELLA VULGARIS (UNII: RYQ4R60M02)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
POLYGLYCERYL-6 DISTEARATE (UNII: Z35I17EQOP)
GLYCERIN (UNII: PDC6A3C0OX)
BETAINE (UNII: 3SCV180C9W)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)
SQUALANE (UNII: GW89575KF9)
NIACINAMIDE (UNII: 25X51I8RD4)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
XANTHAN GUM (UNII: TTV12P4NEE)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
JUNIPER BERRY (UNII: O84B5194RL)
ALLANTOIN (UNII: 344S277G0Z)
FRANGULA ALNUS BARK (UNII: S2D77IH61R)
LEVOMENOL (UNII: 24WE03BX2T)
BASIL (UNII: 2U0KZP0FDW)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
BETULA PUBESCENS LEAF (UNII: 84SOH0O3OO)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81159-387-00	1 in 1 CARTON	04/01/2023
1		59 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/01/2023

Labeler - The Seaweed Bath Co. (030712147)

Establishment
Name	Address	ID/FEI	Business Operations
Sun Deep Inc.		189788201	MANUFACTURE(81159-387)