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 - DAILY DEFENSE MINERAL SPF 50 (77394-202)

ACTIVE INGREDIENTS

Zinc Oxide 21%

PURPOSE

Sunscreen

USES

WARNINGS

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

OTHER INFORMATION

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

01b UC_Daily-Defense-Mineral-SPF50_2oz_BOX_FDA2

LATHER- DAILY DEFENSE MINERAL SPF 50 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77394-202
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION21 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77394-202-131 in 1 BOX04/28/2021
157 g in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:77394-202-0117 g in 1 BOTTLE; Type 0: Not a Combination Product04/28/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/28/2021
Labeler - Lather, Inc. (100666606)

Revised: 10/2023
Document Id: 06d49422-3f8c-f930-e063-6294a90a27eb
Set id: 81cf57b0-6072-432f-b421-7d1a708da1c4
Version: 10
Effective Time: 20231003
 
Lather, Inc.