milky mineral sun serum spray

milky mineral sun serum spray
SPL v2
SPL
SPL Set ID 53834c89-b3b4-4e21-b9f6-19f95e78ba83
Route
topical
Published
Effective Date 2024-11-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
titanium dioxide (72 mg) zinc oxide (95 mg)
Inactive Ingredients
safflower oil coconut alkanes cocoyl caprylocaprate medium-chain triglycerides sunflower oil grape seed oil karum seed oil olive oil argan oil stearic acid polyhydroxystearic acid (2300 mw) .alpha.-tocopherol acetate papaya mango aluminum oxide rice bran levomenol helianthus annuus flowering top squalane rosemary tocopherol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2022-04-01

Description

Drug Facts


Medication Information

Warnings
  • For external use only
Uses
  • helps prevent sunburn
Directions
  • Shake well. Do not spray on face. If using on face, spray onto hands and rub on skin.
  • Apply liberally 15 minutes before sun exposure
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating
  • Children under 6 months: 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 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 & sunglasses
Inactive Ingredients

Carthamus Tinctorius (Safflower) Seed Oil, Coconut Alkanes (And) Coco-Caprylate/Caprate, Caprylic/Capric Triglyceride, Helianthus Annuus (Sunflower) Seed Oil, Vitis Vinifera (Grape) Seed Oil, Pongamia Glabra (Karanja) Seed Oil , Olea Europaea (Olive) Fruit Oil, Argania Spinosa (Argan) Kernel Oil, Stearic Acid, Polyhydroxystearic Acid, Tocopheryl Acetate (Vitamin E), Carica Papaya (Papaya) Fruit Extract, Manifera Indica (Mango) Fruit Extract Alumina, Oryza Sativa (Rice) Bran Extract, Bisabolol, Helianthus Annuus (Sunflower) Extract,

From Sugarcane
Squalane, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopherol,

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1
  • Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Section 50566-9
  • Stop use and ask a doctor if rash occurs
Section 50567-7
  • When using this product keep out of eyes. Rinse with water to remove.
Section 50570-1
  • Do not use on damaged or broken skin
Section 55105-1
Active Ingredient Purpose
Titanium Dioxide (Non-Nano) 7.2% Sunscreen
Zinc Oxide (Non-Nano) 9.5% Sunscreen
Principal Display Panel 100 Ml Bottle Label

sun

tegrity®

MILKY MINERAL

SUN SERUM SPRAY

FOR FACE & BODY

BROAD SPECTRUM SPF 50

SPF

50

WITH ARGAN & KARANJA OIL

MANGO PAPAYA SCENT

Light, Non-Sticky Texture

Vegan | Reef Friendly

3.4 FL OZ (100 ML)


Structured Label Content

Warnings
  • For external use only
Uses
  • helps prevent sunburn
Directions
  • Shake well. Do not spray on face. If using on face, spray onto hands and rub on skin.
  • Apply liberally 15 minutes before sun exposure
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating
  • Children under 6 months: 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 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 & sunglasses
Inactive Ingredients

Carthamus Tinctorius (Safflower) Seed Oil, Coconut Alkanes (And) Coco-Caprylate/Caprate, Caprylic/Capric Triglyceride, Helianthus Annuus (Sunflower) Seed Oil, Vitis Vinifera (Grape) Seed Oil, Pongamia Glabra (Karanja) Seed Oil , Olea Europaea (Olive) Fruit Oil, Argania Spinosa (Argan) Kernel Oil, Stearic Acid, Polyhydroxystearic Acid, Tocopheryl Acetate (Vitamin E), Carica Papaya (Papaya) Fruit Extract, Manifera Indica (Mango) Fruit Extract Alumina, Oryza Sativa (Rice) Bran Extract, Bisabolol, Helianthus Annuus (Sunflower) Extract,

From Sugarcane
Squalane, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopherol,

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)
  • Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Section 50566-9 (50566-9)
  • Stop use and ask a doctor if rash occurs
Section 50567-7 (50567-7)
  • When using this product keep out of eyes. Rinse with water to remove.
Section 50570-1 (50570-1)
  • Do not use on damaged or broken skin
Section 55105-1 (55105-1)
Active Ingredient Purpose
Titanium Dioxide (Non-Nano) 7.2% Sunscreen
Zinc Oxide (Non-Nano) 9.5% Sunscreen
Principal Display Panel 100 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 100 ML Bottle Label)

sun

tegrity®

MILKY MINERAL

SUN SERUM SPRAY

FOR FACE & BODY

BROAD SPECTRUM SPF 50

SPF

50

WITH ARGAN & KARANJA OIL

MANGO PAPAYA SCENT

Light, Non-Sticky Texture

Vegan | Reef Friendly

3.4 FL OZ (100 ML)


Advanced Ingredient Data


Raw Label Data

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