LATHER DAILY DEFENSE MINERAL SPF 45 FACIAL SUNSCREEN- zinc oxide lotion

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

Zinc Oxide 19%

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 cause by the sun.

WARNINGS

For external use only

Do not use on damaged or broken sin

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

DOSAGE & ADMINISTRATION

Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, immediately after towel drying, and at least every 2 hours.

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 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
• children under 6 months: ask a doctor

INACTIVE INGREDIENT

Water (Aqua), Aloe Barbadensis leaf Juice*, Coco-Caprylate/Caprate, Isoamyl Laurate, Glycerin, Polyglyceryl-3 Oleate, Propanediol, Polyhydroxystearic Acid, Diisostearoyl Polyceryl-3 Dime Dilinoleate, Mica, Caprylic/Capric Triglycride, Magnesium Sulfate, Squalane**, Camellia Sineis (Green Tea) Leaf Extract*, Olea Europa (Olive) Leaf Extract*, Curcuma Longa (Turmeeric) Root Extract*, Jojoba Esters, Helianthus Annuus (Sunflower) Seed Oil, Alaria Esculenta (Wakame Seaweed) Extract, Ocimum Tenuiflorum (Tulsi) Leaf Extract*, Ethyl Lauroyl Arginate HCl, Mixed Tocopherols, Sodium Stearoyl Glutamate, Tetrasodium Glutamate Diacetate, Silica, Xanthan Gum, Iron Oxides (CI 77492, CI 44791, CI 77499), *Organic Ingredient **Olive

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LATHER DAILY DEFENSE MINERAL SPF 45 FACIAL SUNSCREEN 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77394-204
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	19 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)
ALARIA ESCULENTA (UNII: EJ9JK8J58D)
GLYCERIN (UNII: PDC6A3C0OX)
OLEA EUROPAEA (OLIVE) LEAF (UNII: MJ95C3OH47)
CI 77491 (UNII: 1K09F3G675)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CI 77499 (UNII: XM0M87F357)
ETHYL LAUROYL ARGINATE HYDROCHLORIDE (UNII: XPD6ZY79TB)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
XANTHAN GUM (UNII: TTV12P4NEE)
CI 77492 (UNII: EX438O2MRT)
TURMERIC (UNII: 856YO1Z64F)
MICA (UNII: V8A1AW0880)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
ISOAMYL LAURATE (UNII: M1SLX00M3M)
POLYGLYCERYL-3 OLEATE (UNII: XRQ165498B)
DIISOSTEAROYL POLYGLYCERYL-3 DIMER DILINOLEATE (UNII: G3232Z5S2O)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
MAGNESIUM SULFATE (UNII: DE08037SAB)
TOCOPHEROL (UNII: R0ZB2556P8)
WATER (UNII: 059QF0KO0R)
ALOE BARBADENSIS LEAF JUICE (UNII: RUE8E6T4NB)
PROPANEDIOL (UNII: 5965N8W85T)
SQUALANE (UNII: GW89575KF9)
HOLY BASIL LEAF (UNII: SCJ765569P)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
SUNFLOWER OIL (UNII: 3W1JG795YI)
HYDROLYZED JOJOBA ESTERS (UNII: UDR641JW8W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77394-204-02	1 in 1 CARTON	05/06/2026
1		56.7 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/06/2026

Labeler - Lather, Inc. (100666606)

Registrant - Stream2Sea (052920828)

Establishment
Name	Address	ID/FEI	Business Operations
Stream2Sea		052920828	manufacture(77394-204)