Label: LATHER- DAILY DEFENSE MINERAL SPF 50- zinc oxide cream
- NDC Code(s): 77394-202-01, 77394-202-13
- Packager: Lather, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated October 3, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNINGS
-
DIRECTIONS
- Apply liberally 15 minutes before sun exposure
- reapply: after 80 minutes of swimming or sweating
- immediately after towel drying
- 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 of age: ask a doctor
- 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
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
LATHER- DAILY DEFENSE MINERAL SPF 50
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77394-202 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 g 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:77394-202-13 1 in 1 BOX 04/28/2021 1 57 g in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:77394-202-01 17 g in 1 BOTTLE; Type 0: Not a Combination Product 04/28/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 04/28/2021 Labeler - Lather, Inc. (100666606)