ESSENTIAL MOISTURIZING SUNSCREEN- zinc oxide lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z), OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

Available from:

Topiderm, Inc.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

- 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.

Authorization status:

OTC monograph final

Summary of Product characteristics

ESSENTIAL MOISTURIZING SUNSCREEN- ZINC OXIDE LOTION
TOPIDERM, 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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ESSENTIAL MOISTURIZING SUNSCREEN
_DRUG FACTS_
_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.
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