ESSENTIAL MOISTURIZING SUNSCREEN- zinc oxide, octinoxate lotion

Essential Moisturizing Sunscreen by

Drug Labeling and Warnings

Essential Moisturizing Sunscreen by is a Otc medication manufactured, distributed, or labeled by Topiderm, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient	Purpose
Zinc Oxide 14.8%	Sunscreen
Octinoxate 7.5%	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.

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

Stop use if signs of irritation or rash appear. If irritation or rash persists consult a doctor.

Keep out of reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

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 of 15 or higher and other sunscreen measures including:

• limit time in the sun, especially from 10 a.m.-2 p.m.
• wear long-sleeve shirts, pants, hats, and sunglasses

Directions

• Apply liberally to face and neck and spread evenly 15 minutes before sun exposure
• Re-apply after swimming, excessive perspiring, or anytime after towel drying
• Use a water resistant sunscreen if swimming or sweating
• Use on children under 6 months of age: consult a doctor.

Inactive ingredients

Purified Water, Diethylhexyl Succinate, Octyldodecyl Neopentanoate, Cetearyl Glucoside, Cetyl Ethylhexanoate, Polyisobutene, Sodium Hyaluronate, Tocopheryl Acetate, Caffeine, Xanthan Gum, Butylene Glycol, Triethoxycaprylylsilane, Oleth-3 Phosphate, Ethylhexyl Stearate, Dimethicone, Sucrose, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, PEG-7 Trimethylolpropane Coconut Ether, Panthenol, Phenoxyethanol, Disodium EDTA.

PRINCIPAL DISPLAY PANEL - 63 g Bottle Label

REPLENiX®
SUNSCREEN

ESSENTIAL
MOISTURIZING
SPF 50

14.8% Micronized Zinc Oxide
Hydrating Hyaluronic Acid
Quick-absorbing Application

BROAD SPECTRUM UVA/UVB SPF 50

Net wt. 2.22 oz. (63 g)

TOPIX PHARMACEUTICALS, INC. N. AMITYVILLE, NY 11701

INGREDIENTS AND APPEARANCE

ESSENTIAL MOISTURIZING SUNSCREEN 
zinc oxide, octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51326-122
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	148 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
POLYISOBUTYLENE (2300 MW) (UNII: DSQ2V1DD1K)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CAFFEINE (UNII: 3G6A5W338E)
XANTHAN GUM (UNII: TTV12P4NEE)
1,3-BUTANEDITHIOL (UNII: 85VJA9KBCH)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
DIMETHICONE (UNII: 92RU3N3Y1O)
SUCROSE (UNII: C151H8M554)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
PEG-7 TRIMETHYLOLPROPANE COCONUT ETHER (UNII: MVJ3AD73GG)
PANTHENOL (UNII: WV9CM0O67Z)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51326-122-20	63 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/09/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M020	01/09/2021

Labeler - Topiderm, Inc. (049121643)

Registrant - Topiderm, Inc. (049121643)

Establishment
Name	Address	ID/FEI	Business Operations
Topiderm, Inc.		049121643	MANUFACTURE(51326-122)