SUNSCREEN BROAD SPECTRUM SPF 55 MOISTURIZING- octinoxate and zinc oxide cream 
Scarsdale Integrative Family Medicine Pllc

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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Sunscreen Broad Spectrum SPF 55 Moisturizing Lotion

DRUG FACTS

ACTIVE INGREDIENTS

Octinoxate 7.5%

Zinc Oxide 4.8%

PURPOSE

Sunscreen

USES

Help prevent sunburn.

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 or irritation occurs.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

Apply liberally and evenly 15 minutes before sun exposure. 1Reapply:

At least 80 minutes after swimming or sweating, immediately after towel drying, at least every 2 hours.


1
For children under 6 months of age: Ask a doctor.

INACTIVE INGREDIENTS

Water, Hydrogenated Polybutene, Octyl Stearate, Polyglyceryl-4-Isostearate, Aloe Barbadensis Leaf Extract, Isopropyl Palmitate, Cyclomethicone, Sunflower Oil, Hydrogenated Microcrystalline Wax, Cetyl Dimethicone Copolyol, Cetyl Dimethicone, Hydrogenated Castor Oil, Sodium Chloride, Polyglyceryl-3-Oleate, Silica, Hexyl Laurate, Triethoxycaprylylsilane, Capryly Glycol, Methylisothiazolinone.

OTHER INFORMATION

Store at controlled temperature 15C – 30C (59F-86F). Protect the product in this container from excessive heat and direct sun.

See Beyond

3See Beyond

Scarsdale Aesthetic Medicine

Dynamic Broad Spectrum

Snscreen SPF 55
Sun Protection

1.75 fl Oz (50ml)

SUNSCREEN BROAD SPECTRUM SPF 55 MOISTURIZING 
octinoxate and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81413-5550
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 OXIDE48 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISOCETYL STEARATE (UNII: 3RJ7186O9W)  
SORBITOL (UNII: 506T60A25R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
ALCOHOL (UNII: 3K9958V90M)  
OCTISALATE (UNII: 4X49Y0596W)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
BETULA PUBESCENS BARK (UNII: 3R504894L9)  
GARDEN CRESS SPROUT (UNII: PWQ18YNR62)  
SAGE (UNII: 065C5D077J)  
COLA ACUMINATA SEED (UNII: 1F8VIW1479)  
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ISOMALT (UNII: S870P55O2W)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81413-5550-250 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/22/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/22/2021
Labeler - Scarsdale Integrative Family Medicine Pllc (004329015)

Revised: 1/2021
Document Id: b985508d-a428-2d40-e053-2a95a90a3ab6
Set id: b9856818-4e23-ebfe-e053-2a95a90a6b4e
Version: 1
Effective Time: 20210122
 
Scarsdale Integrative Family Medicine Pllc