REVITALIZING MOISTURIZING SUNSCREEN SPF 20- octocrylene and octinoxate and avobenzone cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM), OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)

Available from:

GENOME COSMETICS, LLC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Sunscreen - helps prevent sunburn

Authorization status:

OTC monograph final

Summary of Product characteristics

REVITALIZING MOISTURIZING SUNSCREEN SPF 20- OCTOCRYLENE AND OCTINOXATE
AND
AVOBENZONE CREAM
GENOME COSMETICS, 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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REVITALIZING MOISTURIZING SUNSCREEN CREAM - SPF-20
ACTIVE INGREDIENT
OCTOCRYLENE 10.0%
OCTINOXATE 7.5%
AVOBENZONE 3.0%
PURPOS E
Sunscreen
US ES
helps prevent sunburn
WARNINGS
FOR EXTERNAL USE ONLY.
DO NOT APPLY TO
irritated or broken skin.
WARNINGS
CONSULT A DOCTOR
Stop use and consult a doctor if rash occurs.
WARNINGS
STOP USE
Stop use and consult a doctor if rash occurs
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
right away.
DIRECTIONS
Gently massage onto all areas of the face using a circular motion 15
minutes prior
to sun exposure
Reapply every two hours
For children under 6 months of age, ask a doctor
SKIN CANCER/SKIN AGING ALERT: Spending time in the sun increases your
risk of skin cancer and
early skin aging.
OTHER INFORMATION
protect the product in this container from excessive heat and direct
sun
INACTIVE INGREDIENTS
Water (AQUA, EAU), Helianthus Annuus Seed Oil, Cetearyl Alcohol,
Limnanthes Alba, Carthamus
Tinctorius (SAFFLOWER) Seed Oil, Meadowfoam Estolide, Polysorbate-60,
Crambe Abyssinica Seed
Oil, Simmondsia Chinesis (JOJOBA) Seed Oil, Meadowfoam Delta-Lactone,
Olea Europaea (OLIVE)
Oil Unsaponifiables, PEG-40 Hydrogenated Castor Oil,
Meadowfoamamidopropyl Betaine,
Dimethicone PEG-8 Meadowfoamate, Steareth-20, Polysorbate-65,
Phenoxyethanol, Carbomer,
Panthenol, Phytosterol, Aminomethylpropanol, CI15985 (YELLOW 6),
Tocopheryl Acetate, Fragrance
(Parfum), Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol,
Cholecalciferol, Calendula
Officinalis Flower Extract, Anthemis Nobilis (CHAMOMILE) Flower
Extract, Beta Sitosterol,
Tripeptide-10 Citrulline, Ubiquinone Q10, Sea Salt, Glycine Soja
(Soybean) Oil, Oenothera Biennis
(