LATHER (as PLD) - DAILY DEFENSE MINERAL SPF 50 (77394-201)

LATHER- DAILY DEFENSE MINERAL SPF 50 by

Drug Labeling and Warnings

LATHER- DAILY DEFENSE MINERAL SPF 50 by is a Otc medication manufactured, distributed, or labeled by Lather, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LATHER- DAILY DEFENSE MINERAL SPF 50- zinc oxide cream 
Lather, 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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LATHER (as PLD) - DAILY DEFENSE MINERAL SPF 50 (77394-201)

ACTIVE INGREDIENTS

Zinc Oxide 21%

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

DIRECTIONS

• Apply liberally 15 minutes before sun exposure
• reapply: after 80 minutes of swimming or sweating
• immediatley after towel drying
• at least every 2 hours
• Sun Protection Measures. Spending time inthe sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPFvalue of 15 or higher and other sun protectionmeasures 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 of age: ask a doctor

OTHER INFORMATION

Protect the product in this container from excessive heat and direct sun.

INACTIVE INGREDIENTS

Water (aqua), Coco-Caprylate/Caprate, Cetearyl Alcohol, Propanediol, Stearyl Alcohol, Polyhydroxystearic Acid, Mica, Butyrospermum Parkii (Shea) Butter, Cetearyl Olivate, Sorbitan Olivate, Camellia Sinensis (Green Tea) Extract, Olea Europaea (Olive) Leaf Extract, Equisetum Arvense (Horsetail) Extract, Rosmarinus Officinalis (rosemary) Extract, Centella Asiatica (Gotu Kola) Extract, Aesculus Hippocastanum (Horse Chestnut) Extract, Cocos Nucifera (Coconut) Oil, Helianthus Annuus (Sunflower) Seed Oil, Glyceryl Caprylate, Glycerin, Xanthan Gum, Tocopheryl Acetate, Citrus Nobilis (Mandarin Orange) Peel Oil, Silica, Caprylhydroxamic Acid, Triethoxycaprylylsilane, Ascorbyl Palmitate, Caprylic/Capric Triglyceride, Ascorbic Acid, Tocopherol, Potassium Sorbate, Sodium Phytate, Citric Acid, Iron Oxides

LATHER- DAILY DEFENSE MINERAL SPF 50

LATHER- DAILY DEFENSE MINERAL SPF 50 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77394-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	21 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
CETYL ALCOHOL (UNII: 936JST6JCN)
PROPANEDIOL (UNII: 5965N8W85T)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
MICA (UNII: V8A1AW0880)
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
SORBITAN OLIVATE (UNII: MDL271E3GR)
CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)
EQUISETUM ARVENSE WHOLE (UNII: 73DM367W4P)
ROSMARINUS OFFICINALIS FLOWER (UNII: NR1A27F29O)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
AESCULUS HIPPOCASTANUM FLOWER (UNII: KK0Z92II8M)
COCOS NUCIFERA WHOLE (UNII: 245J88W96L)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
GLYCERIN (UNII: PDC6A3C0OX)
XANTHAN GUM (UNII: TTV12P4NEE)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CITRUS NOBILIS (UNII: 8MFF77J91V)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CAPRYLIC/CAPRIC/SUCCINIC TRIGLYCERIDE (UNII: J4BY50FL78)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
TOCOPHEROL (UNII: R0ZB2556P8)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PHYTATE SODIUM (UNII: 88496G1ERL)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
BROWN IRON OXIDE (UNII: 1N032N7MFO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77394-201-22	1 in 1 BOX	04/28/2021	05/01/2021
1		57 mL in 1 BOTTLE, DISPENSING; 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	04/28/2021	05/01/2021

Labeler - Lather, Inc. (100666606)

Revised: 10/2023

Document Id: 06d48cc9-3f9a-f0ea-e063-6294a90af3e5

34390-5

Set id: a0d03d13-ac24-48b6-b029-4dac673c03c9

Version: 6

Effective Time: 20231003

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