SKIN REJUVENATING DAILY MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN- octinoxate and zinc oxide cream 
Dermaset, 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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SKIN REJUVENATING DAILY MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN

DRUG FACTS:

ACTIVE INGREDIENTS

Octinoxate 7.5%, Zinc Oxide 10.0%.

Purpose

Sunscreen

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 to all skin exposed to the sun. *Apply liberally and evenly 15 minutes before sun exposure. *Reapply at least every 2 hours. *Use a water-resistant sunscreen if swimming or sweating. *For 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 decrease 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.

INACTIVE INGREDIENTS

Ž­‘Water (Aqua), Butyloctyl Salicylate, Glycerin, Dimethicone, Styrene/Acrylates Copolymer, Coco-Caprylate/Caprate, Caprylic/Capric Triglyceride, VP/Eicosene Copolymer, Carthamus Tinctorius Oleosomes, Elettaria Cardamomum Seed Extract, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Perilla Frutescens Extract, Pyrus Malus (Apple) Fruit Extract, Rose Extract, Santalum Album Extract, Camellia Sinensis Leaf Extract, Anthemis Nobilis Flower Extract, Cananga Odorata Flower Extract, Citrus Aurantium Dulcis (Orange) Peel Extract, Cucumis Melo (Melon) Fruit Extract, Cucumis Sativus Fruit Extract, Jasminum Officinale Flower/Leaf Extract, Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, Rubus Idaeus (Raspberry) Fruit Extract, Polygonum Aviculare Extract, Vitis Vinifera Fruit Cell Extract, Propanediol, Cetearyl Alcohol, Pentylene Glycol, Arachidyl Alcohol, Polyhydroxystearic Acid, Coco-Glucoside, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Behenyl Alcohol, Xanthan Gum, Triethoxycaprylylsilane, Arachidyl Glucoside, Phenethyl Alcohol, Caprylyl Glycol.

OTHER INFORMATION

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

PRINCIPAL DISPLAY PANEL - 29g Tube Label

DermaSet™
HOLLYWOOD SKINCARE

SPF
30

SKIN REJUVENATING

DAILY MOISTURIZER
BROAD SPECTRUM SPF 30 SUNSCREEEN

For Face & Neck

29g - Net Wt.1 Oz

PRINCIPAL DISPLAY PANEL - 29g Tube Label
SKIN REJUVENATING DAILY MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN 
octinoxate and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80873-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)  
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)  
CARDAMOM (UNII: 8BC4CUT4JL)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PERILLA FRUTESCENS SEED (UNII: 8M62PUD356)  
APPLE (UNII: B423VGH5S9)  
SANTALUM ALBUM SEED (UNII: 7RZT0U509Y)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
CANANGA ODORATA FLOWER (UNII: 76GTF6Z97M)  
ORANGE PEEL (UNII: TI9T76XD44)  
MUSKMELON (UNII: ZV095H5633)  
JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)  
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
RASPBERRY (UNII: 4N14V5R27W)  
POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)  
PROPANEDIOL (UNII: 5965N8W85T)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
COCO GLUCOSIDE (UNII: ICS790225B)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
DOCOSANOL (UNII: 9G1OE216XY)  
XANTHAN GUM (UNII: TTV12P4NEE)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80873-100-0129 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product10/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35210/30/2020
Labeler - Dermaset, Inc. (117655065)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetic Solutions807907928MANUFACTURE(80873-100)

Revised: 1/2022
Document Id: 3e4d9974-42f9-4ecf-bfc8-97edd048ea1e
Set id: 8b750d84-d638-4ed8-859d-38add9a0e1d7
Version: 2
Effective Time: 20220114
 
Dermaset, Inc.