LIGHT HEARTED BROAD SPECTRUM SPF 30 SUNSCREEN- octisalate, octocrylene, zinc oxide lotion 
Sunday Riley Modern Skincare, LLC

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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LIGHT HEARTED BROAD SPECTRUM SPF 30 SUNSCREEN LOTION

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

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

Distributed By

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

PACKAGE LABEL

image description

LIGHT HEARTED BROAD SPECTRUM SPF 30 SUNSCREEN 
octisalate, octocrylene, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73001-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate5 g  in 100 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene3.5 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION16.32 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73001-005-451 in 1 BOX04/16/2021
145 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/16/2021
Labeler - Sunday Riley Modern Skincare, LLC (012302640)

Revised: 11/2021
Document Id: 616b904f-62f4-4309-a7f4-088d436b7287
Set id: 3d02b359-ced1-4a3b-a4d1-97f02a7e717e
Version: 1
Effective Time: 20211123
 
Sunday Riley Modern Skincare, LLC