LIGHT HEARTED BROAD SPECTRUM SPF 30 SUNSCREEN- octisalate, octocrylene, zinc oxide lotion

LIGHT HEARTED BROAD SPECTRUM SPF 30 SUNSCREEN by

Drug Labeling and Warnings

LIGHT HEARTED BROAD SPECTRUM SPF 30 SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by Sunday Riley Modern Skincare, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Octisalate 5%
Octocrylene 3.5%
Zinc Oxide 16.32% 

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

Keep out of reach of Children

Directions

Apply generously 15 minutes before sun exposure
Children under 6 months of age: Ask a doctor
Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decreases this risk, regularly use a sunscreen with a Broad Spectrum SPF value 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-sleeved shirts, pants, hats, and sunglasses
Reapply at least every 2 hours
Use a water resistant sunscreen if swimming or sweating

Inactive Ingredients

Water/Eau/Aqua, Octyldodecanol, Dimethicone, Alcohol Denat., Polypropylsilsesquioxane, C12-C15 Alkyl Benzoate , Cyclopentasiloxane, Polyhydroxystearic Acid, Cetyl Diglyceryl Tris (Trimethylsiloxy) silylethyl Dimethicone, Isododecane, PPG-24-Glycereth-24, Curcuma Longa (Turmeric) Root Extract, Xanthophyll, Melia Azadirachta Leaf Extract, Melia Azadirachta Flower Extract, Corallina Officinalis Extract, Betaine, Coccinia Indica Fruit extract, Dimethicone/Vinyl Dimethicone Crosspolymer, Octyldodecyl Xyloside, PEG-30 Dipolyhydroxystearate, Magnesium stearate, Triethoxycaprylysilane, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Dimethicone Crosspolymer, Carthamus Tinctorius (Saffflower) seed oil, Methylpropanediol, Caprylyl Glycol, Polyquaternium-80, Didecyldimonium Chloride, Magnesium Sulphate, Sodium Chloride, Magnesium Myristate

Other Information

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

SPL UNCLASSIFIED SECTION

Distributed By

Sunday Riley Modern Skincare, LLC
Houston, Texas (TX) 77027, USA

PACKAGE LABEL

INGREDIENTS AND APPEARANCE

LIGHT HEARTED BROAD SPECTRUM SPF 30 SUNSCREEN 
octisalate, octocrylene, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73001-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	5 g  in 100 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	3.5 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	16.32 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Octyldodecanol (UNII: 461N1O614Y)
Dimethicone (UNII: 92RU3N3Y1O)
ALCOHOL (UNII: 3K9958V90M)
PROPYLSILSESQUIOXANE, HYDROGEN TERMINATED (UNII: 2PDG9JR76G)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
ISODODECANE (UNII: A8289P68Y2)
PPG-24-GLYCERETH-24 (UNII: V341SPY84U)
TURMERIC (UNII: 856YO1Z64F)
LUTEIN (UNII: X72A60C9MT)
AZADIRACHTA INDICA LEAF (UNII: HKY915780T)
AZADIRACHTA INDICA FLOWER (UNII: 3TE8A92UPM)
CORALLINA OFFICINALIS (UNII: 4004498D06)
BETAINE (UNII: 3SCV180C9W)
COCCINIA GRANDIS FRUIT (UNII: VLJ6WOT3K5)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
OCTYLDODECYL XYLOSIDE (UNII: 8Z6VNR46QM)
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER (UNII: RSA9I561OK)
SAFFLOWER OIL (UNII: 65UEH262IS)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73001-005-45	1 in 1 BOX	04/16/2021
1		45 mL in 1 TUBE; 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	04/16/2021

Labeler - Sunday Riley Modern Skincare, LLC (012302640)