LARKLY SPF30 MINERAL POWDER FACE SUNSCREEN- titanium dioxide and zinc oxide powder

Larkly SPF30 Mineral Powder Face Sunscreen by

Drug Labeling and Warnings

Larkly SPF30 Mineral Powder Face Sunscreen by is a Otc medication manufactured, distributed, or labeled by LARKLY, LLC, Cosco International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient...........................Purpose

Titanium Dioxide 21.00%..................Sunscreen

Zinc Oxide 15.00%..........................Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early aging caused by the sun

Warnings

For external use only

DO NOT USE

Do not use on damaged or borken skin

WHEN USING

When using this product keep out of eyes. Rinse with water to remove

STOP USE

Stop use and ask a doctor if rash occurs

KEEP OUT OF REACH OF CHILDREN

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
• immediately after towel drying 
• at least every 2 hours
• children under 6 months: Ask a doctor   

Inactive Ingredients

Alpha-Tocopherol, Caprylic/Capric Triglyceride, Capryloyl Glycerin, Ceramide I, Ceramide II, Ceramide III, Ethylhexylglycerin, Fumed Silica, Glycyrrhiza Glabra, Green Tea Leaf, Iron Oxide Black, Iron Oxide Red, Iron Oxide Yellow, Kaolin, Magnesium Hydroxide, Maranta Arundinacea Root, Mica, Glyceryl Caprylate, Glycerin, Caprylhydroxamic Acid, Resveratol, Sebacic Acid Copolymer, Tapioca Starch

Questions or Comments?

Call toll free:  1-888-426-4160

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LARKLY SPF30 MINERAL POWDER FACE SUNSCREEN 
titanium dioxide and zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79287-0000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.212 kg  in 1 kg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.15 kg  in 1 kg

Inactive Ingredients
Ingredient Name	Strength
.ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
CERAMIDE 1 (UNII: 5THT33P7X7)
CERAMIDE 2 (UNII: C04977SRJ5)
CERAMIDE 3 (UNII: 4370DF050B)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HEXAMETHYLDISILAZANE (UNII: H36C68P1BH)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S)
MARANTA ARUNDINACEA ROOT (UNII: FVN346W31A)
MICA (UNII: V8A1AW0880)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
RESVERATROL (UNII: Q369O8926L)
STARCH, TAPIOCA (UNII: 24SC3U704I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79287-0000-2	1 in 1 BOX	07/10/2020
1	NDC: 79287-0000-1	0.006 kg in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
2	NDC: 79287-0000-4	1 in 1 BOX	07/10/2020
2	NDC: 79287-0000-3	0.006 kg in 1 JAR; 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	07/10/2020

Labeler - LARKLY, LLC (042886441)

Establishment
Name	Address	ID/FEI	Business Operations
Cosco International, Inc.		016433141	manufacture(79287-0000)