Vanicream Facial Moisturizer Broad Spectrum Spf30

Vanicream Facial Moisturizer Broad Spectrum Spf30
SPL v6
SPL
SPL Set ID d8c9a8d0-1f24-2240-e053-2a95a90a8dee
Route
TOPICAL
Published
Effective Date 2024-10-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (19.5 g)
Inactive Ingredients
Carnosine Soy Sterol Hydrogenated Soybean Lecithin Ceramide Np Ceramide 5 Dimethicone Caprylyl Glycol Glyceryl 1-stearate Peg-100 Stearate Polyhydroxystearic Acid (2300 Mw) Isopentyldiol Cetostearyl Alcohol Alkyl (c12-15) Benzoate Water Squalane Glycerin Ceramide Ng Triethoxycaprylylsilane Ammonium Acryloyl Dimethyltaurate/methacrylate, Dimethylacrylamide And Methacrylic Acid Copolymer, Ppg-3 Glyceryl Triacrylate Crosslinked (100000 Mw) 1,2-hexanediol Cocoyl Caprylocaprate Bis-octyldodecyl Dimer Dilinoleate/propanediol Copolymer Sucrose Stearate Ceramide 1 Ceramide Ap

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-03-15 Until 2025-11-30

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

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
Dosage and Administration

Directions

  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use water resistant sunscreen if swimming or sweating
  • 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
Description

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

Other information

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

Section 50565-1

Keep out of reach of children. If 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 51727-6

Inactive ingredients water, C12-15 alkyl benzoate, isopentyldiol, squalane, glycerin, coco-caprylate/caprate, bis-octyldodecyl dimer dilinoleate/propanediol copolymer, glyceryl stearate, PEG-100 stearate, polyhydroxystearic acid, cetearyl alcohol, sucrose stearate, ceramide EOP, ceramide NG, ceramide NP, ceramide AS, ceramide AP, carnosine, phytosterols, hydrogenated lecithin, dimethicone, triethoxycaprylylsilane, polyacrylate crosspolymer-11, caprylyl glycol, 1,2-hexanediol

Section 51945-4

NDC 45334-325-02

DERMATOLOGIST TESTED

VANICREAM™ Facial Moisturizer

BROAD SPECTRUM SPF 30

ZINC OXIDE SUNSCREEN WITH CERAMIDES

FOR SENSITIVE SKIN

Free of dyes, fragrance, masking fragrance, lanolin, parabens & formaldehyde releasers

Non-comedogenic

Gluten-free

Net Wt 2.5 oz (71 g)

PHARMACEUTICAL SPECIALTIES, INC.

ROCHESTER, MN 55901

1-800-325-8232

Made in USA with select US and imported materials

Section 53413-1

Questions or Comments? 1-800-325-8232

Section 55105-1

Purpose

Sunscreen

Section 55106-9

Active ingredient

Zinc oxide 19.5%


Structured Label Content

Indications and Usage (34067-9)

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
Dosage and Administration (34068-7)

Directions

  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use water resistant sunscreen if swimming or sweating
  • 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
Warnings and Precautions (34071-1)

Warnings

For external use only

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

Other information

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

Section 50565-1 (50565-1)

Keep out of reach of children. If 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 51727-6 (51727-6)

Inactive ingredients water, C12-15 alkyl benzoate, isopentyldiol, squalane, glycerin, coco-caprylate/caprate, bis-octyldodecyl dimer dilinoleate/propanediol copolymer, glyceryl stearate, PEG-100 stearate, polyhydroxystearic acid, cetearyl alcohol, sucrose stearate, ceramide EOP, ceramide NG, ceramide NP, ceramide AS, ceramide AP, carnosine, phytosterols, hydrogenated lecithin, dimethicone, triethoxycaprylylsilane, polyacrylate crosspolymer-11, caprylyl glycol, 1,2-hexanediol

Section 51945-4 (51945-4)

NDC 45334-325-02

DERMATOLOGIST TESTED

VANICREAM™ Facial Moisturizer

BROAD SPECTRUM SPF 30

ZINC OXIDE SUNSCREEN WITH CERAMIDES

FOR SENSITIVE SKIN

Free of dyes, fragrance, masking fragrance, lanolin, parabens & formaldehyde releasers

Non-comedogenic

Gluten-free

Net Wt 2.5 oz (71 g)

PHARMACEUTICAL SPECIALTIES, INC.

ROCHESTER, MN 55901

1-800-325-8232

Made in USA with select US and imported materials

Section 53413-1 (53413-1)

Questions or Comments? 1-800-325-8232

Section 55105-1 (55105-1)

Purpose

Sunscreen

Section 55106-9 (55106-9)

Active ingredient

Zinc oxide 19.5%


Advanced Ingredient Data


Raw Label Data

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