GUIDANCE TO GLOW TRU SPF 35

Manufacturer
GUIDANCE TO GLOW SKIN CARE
Effective date
2024-06-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:14:12

Label at a glance#

ProductGUIDANCE TO GLOW TRU SPF 35
Active ingredientZINC OXIDE
Label structure8 sections

Indications and uses

Helps Prevent Sunburn Higher SPF gives more sunburn protection Retains SPF after 80 minutes of swimming or sweating If used as directed with other sun protection measures (see directions) Decreases the risk ok skin cancer and early skin aging caused by the sun

Dosage and administration

Apply liberally 15 minutes before sun exposure and as needed Children under 6 months of age: ask a doctor Reapply  After 80 minutes of swimming or sweating Immediately after towel drying Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk. Regularly use sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures in...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 12%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses:

INDICATIONS & USAGE SECTION

  • Helps Prevent Sunburn
  • Higher SPF gives more sunburn protection
  • Retains SPF after 80 minutes of swimming or sweating
  • If used as directed with other sun protection measures (see directions)

Decreases the risk ok skin cancer and early skin aging caused by the sun

Warnings:

WARNINGS SECTION

For external use ONLY

Do not use

OTC - DO NOT USE SECTION

on damaged skin

When using this product:

OTC - WHEN USING SECTION

keep out of eyes Rinse with water to remove

Stop use and ask a doctor:

OTC - STOP USE SECTION

Rash or irritation develops and lasts

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed,get medical help or contact a poison control center right way.

If pregnant or breastfeeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure and as needed
  • Children under 6 months of age: ask a doctor
  • Reapply 
  • After 80 minutes of swimming or sweating
  • Immediately after towel drying
  • Sun Protection Measures.

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk. Regularly use sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including

  • Limit time in the sun especially from 10a.m - 2 p.m
  • Wear long-sleeve shirts, pants, hats, and sunglasses

Other information

SPL UNCLASSIFIED SECTION

Protect the product in this container from excessive heat and direct sun.

Water Resistant 80 minutes.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), a-Bisabalol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Camellia Sinensis (Green Tea) Extract, Caprylic/Capris Triglyceride, Caprylyl Glycol, Cetearyl Alcohol, Citric Acid, Cocos Nucifera (Coconut) Oil, Daucus Carota Sativa (Carrot) Extract, Dodecane, Glycerin, Glyceryl Laurate, Glyceryl Stearate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Oil, Hydrolyzed Oat Protein, Isododecane, C13-14 Isoparaffin, Laureth-7, Magnesium Aluminum Silicate, Malus Domestica (Apple) Extract Phenoxyethanol, Plankton Extract, Polyacrylamide, Polyhydroxystearic Acid, Polysorbate-20, Potassium Sorbate, Sodium Hyaluronate, Sodium Stearoyl Glutamate, Squalane, Tetrasodium Glutamate Diacetate, Tocopheryl Acetate (Vitamin E), Trimethylsiloxysilicate, Xanthan Gum, Zemea (Corn) Propanediol

Any Questions?

OTC - QUESTIONS SECTION

818-863-6299

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84444-506-00GUIDANCE TO GLOW TRU SPF 3550 mL in 1 TUBECREAM501
84444-506-00GUIDANCE TO GLOW TRU SPF 351 in 1 BOXCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84444-506GUIDANCE TO GLOW TRU SPF 35 (ZINC OXIDE) CREAM [GUIDANCE TO GLOW SKIN CARE]1Current NDC, 2 package rows20240627_21b4747b-b173-43c9-b0d4-1dbba5775ff8.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84444-50684444-506-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GUIDANCE TO GLOW TRU SPF 35ZINC OXIDEGUIDANCE TO GLOW SKIN CARE21b4747b-b173-43c9-b0d4-1dbba5775ff82024-06-25WarningsExact identifier
ndc (package): 84444-506-00
ndc (product): 84444-506
ndc11 (package): 84444050600
spl id: 1bb558bf-848a-1991-e063-6394a90a03d8
spl set id: 21b4747b-b173-43c9-b0d4-1dbba5775ff8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.