Sunscreen Gel Color Broad spectrum SPF 50+

Manufacturer: CryoGen, LLC
Effective date: 2023-11-17
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 00:03:02

Label at a glance#

ProductSunscreen Color Broad spectrum SPF 50

Active ingredientTITANIUM DIOXIDE, ZINC OXIDE

Label structure7 sections

Indications and 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

For sunscreen use: apply liberally and evenly 15 minutes before sun exposure apply to all skin exposed to the sun reapply at least every 2 hours use a 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 Sp...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 10%

Zinc Oxide 5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occurs

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 away.

Directions

DOSAGE & ADMINISTRATION SECTION

For sunscreen use:

apply liberally and evenly 15 minutes before sun exposure
apply to all skin exposed to the sun
reapply at least every 2 hours
use a 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

Other information

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Human Umbilical Mesenchymal Stem Cell Exosomes, Oat (Avena sativa) Extract, Stearic Acid, Sorbitan Stearate, Glycerin, Iron Oxide, Hydroxyacetophenone, Fragrance

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label0

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
ZINC CATION Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
83802-001-01	2025-01-30	C162847	48780-1	2cef2736-b67e-d83d-e063-dadaa90ab31f	Sunscreen Gel Color Broad spectrum SPF 50+

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
83802-001-01	Sunscreen Color Broad spectrum SPF 50	30 mL in 1 BOTTLE, PLASTIC	GEL	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83802-001	SUNSCREEN COLOR BROAD SPECTRUM SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) GEL [CRYOGEN, LLC]	1	1 package rows	20231201_88ff331f-edd9-4a04-a780-f99e1ef557fb.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

Sunscreen Color Broad spectrum SPF 50
TITANIUM DIOXIDE, ZINC OXIDE
WATER
OAT
STEARIC ACID
SORBITAN MONOSTEARATE
GLYCERIN
FERRIC OXIDE RED
HYDROXYACETOPHENONE
TITANIUM DIOXIDE
ZINC OXIDE
ZINC CATION

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
83802-001	83802-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
OAT	Z6J799EAJK	IACT
STEARIC ACID	4ELV7Z65AP	IACT
SORBITAN MONOSTEARATE	NVZ4I0H58X	IACT
GLYCERIN	PDC6A3C0OX	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
HYDROXYACETOPHENONE	G1L3HT4CMH	IACT
TITANIUM DIOXIDE	15FIX9V2JP	ACTIB
ZINC OXIDE	SOI2LOH54Z	ACTIM

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
0a5a4a8d-f942-3ca0-e063-6394a90a222a			88ff331f-edd9-4a04-a780-f99e1ef557fb	2023-11-17	Warnings	Exact identifier spl id: 0a5a4a8d-f942-3ca0-e063-6394a90a222a spl set id: 88ff331f-edd9-4a04-a780-f99e1ef557fb

Reported adverse events (FAERS/openFDA)#

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