Moisturizing Tint
FDA Label NDC 60541-0706

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hayden Caleel Llc for the product Moisturizing Tint (NDC 60541-0706). 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 other, active ingredients:, purpose:, uses, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Other

Drug Facts

Active Ingredients:

Avobenzone (3.0%)

Octinoxate (7.5%)

Octisalate (5.0%)

Oxybenzone (4.0%)

Purpose:

Sunscreen

Uses

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), helps decrease the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Otc - Do Not Use

Do not use on damaged or broken skin.

Otc - When Using

When using this product keep out of the eyes. Rinse with water to remove.

Otc - Stop Use

Stop use and ask a doctor if skin rash occurs.

Otc - Keep Out Of Reach Of Children

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

Directions

  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • Children under 6 months of age: Ask a doctor
  • 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 value of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m. – 2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses

Other Information

  • protect the product in this container from excessive heat and direct sun

Inactive Ingredients

Aqua (Water/Eau)

Isoeicosane

Potassium Cetyl Phosphate

Cetearyl Alcohol

Cetyl Dimethicone

Dimethicone

Ethyhexyl Methoxycrylene

Glycerin

Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer

Silica

Sorbitan Sesquioleate

Isohexadecane

Phenoxyethanol

Caprylyl Glycol

Ethylhexylglycerin

Polysorbate 60

Hexylene Glycol

Citric Acid

MAY CONTAIN (+/-):

Titanium Dioxide (CI 77891)

Iron Oxides (CI 77491, CI 77492, CI 77499)

Principal Display Panel - 50Ml Carton Label

SUNSCREEN

broad
spectrum
spf 30

glo·therapeutics

Moisturizing
Tint SPF 30+

FAIR

FACIAL SUNSCREEN

50 mL / 1.7 fl. oz. e

Principal Display Panel (50mL Carton Label)

Principal Display Panel (50mL Carton Label)

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