Revitalizing Moisturizing Sunscreen Spf 20
FDA Label NDC 61791-126

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Genome Cosmetics, Llc for the product Revitalizing Moisturizing Sunscreen Spf 20 (NDC 61791-126). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, keep out of reach of children., directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

OCTOCRYLENE 10.0%

OCTINOXATE 7.5%

AVOBENZONE 3.0%

Purpose

Sunscreen

Uses

  • helps prevent sunburn

Warnings

For external use only.

Do not apply to

  • irritated or broken skin.

    • Consult a doctor

    • Stop use and consult a doctor if rash occurs.

      • 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 (EVENING PRIMROSE) Oil (OMEGA-3), Borago Officinalis (BORAGE) Seed Oil (OMEGA-6), Aloe Barbadensis Leaf Juice, Algae Extract, Hippophae Rhamnoides (SEA BUCKTHORN) Extract. PARABEN-FREE

Package/Label Principal Display Panel

DARK & BEAUTY REVITALIZING MOISTURIZING CREAM SPF-20

Manufactured for and exclusively distributed by:

Genome Cosmetics LLC

Bensalem, PA 19020 USA

Made in the U.S.A

Age Control Label (3b4b668e 03f5 4286 B0a6 67412768c173 01)

Age Control Label (3b4b668e 03f5 4286 B0a6 67412768c173 01)

Carton Label

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