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NDC 13630-0248-04 Sun Bum 25.8; 129; 43; 60.2 mg/mL; mg/mL; mg/mL; mg/mL Details

Sun Bum 25.8; 129; 43; 60.2 mg/mL; mg/mL; mg/mL; mg/mL

Sun Bum is a TOPICAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Prime Packaging, Inc.. The primary component is AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE.

Product Information

NDC	13630-0248
Product ID	13630-0248_e673e040-5941-f9dd-e053-2995a90a0917
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Sun Bum
Proprietary Name Suffix	Broad Spectrum SPF 50
Non-Proprietary Name	Avobenzone, Homosalate, Octisalate, Octocrylene
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	TOPICAL
Active Ingredient Strength	25.8; 129; 43; 60.2
Active Ingredient Units	mg/mL; mg/mL; mg/mL; mg/mL
Substance Name	AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Labeler Name	Prime Packaging, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	M020
Listing Certified Through	2024-12-31

Package

Package Images

NDC 13630-0248-04 (13630024804)

Pricing Information	N/A
NDC Package Code	13630-0248-4
Billing NDC	13630024804
Package	198 mL in 1 CAN (13630-0248-4)
Marketing Start Date	2019-02-20
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e673e040-5940-f9dd-e053-2995a90a0917 Details

Active Ingredients

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 7%

Purpose

Sunscreen

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

Warnings

For external use only

Flammable: do not use near heat, flame, or while smoking

Do not use on damaged or broken skin

When using this product

Keep out of eyes. Rinse with water to remove.
use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120ºF.

Stop use and ask a doctor if rash occurs

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

Directions

shake well before use
hold container 4 to 6 inches from the skin to apply
spray liberally and spread evenly by hand 15 minutes before sun exposure
do not spray directly into face. Spray on hands then apply to face.
do not apply in windy conditions. use in a well-ventilated area.
reapply:
after 80 minutes of swimming or sweating
immediately after towel drying
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 & sunglasses

Other information

protect this product from excessive heat and direct sun

Inactive ingredients

alcohol denat. (67%), acrylates/octylacrylamide copolymer, C12-15 alkyl benzoate, dicaprylyl carbonate, PPG-5-ceteth-20, fragrance, tocopherol

Questions?

1-877-978-6286

Sun Bum Broad Spectrum SPF 50 Sunscreen Spray

INGREDIENTS AND APPEARANCE

SUN BUM BROAD SPECTRUM SPF 50

avobenzone, homosalate, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13630-0248
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	25.8 mg in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	129 mg in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	43 mg in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	60.2 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
TOCOPHEROL (UNII: R0ZB2556P8)
ALCOHOL (UNII: 3K9958V90M)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
PPG-5-CETETH-20 (UNII: 4AAN25P8P4)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)

Product Characteristics
Color	yellow (light Yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13630-0248-4	198 mL in 1 CAN; Type 0: Not a Combination Product	02/20/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M020	02/20/2019

Labeler - Prime Packaging, Inc. (805987059)

Registrant - Prime Packaging, Inc. (805987059)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Enterprises, Inc.		101946028	manufacture(13630-0248) , analysis(13630-0248)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Packaging, Inc.		805987059	label(13630-0248) , pack(13630-0248)

Revised: 8/2022

Document Id: e673e040-5941-f9dd-e053-2995a90a0917

Set id: e673e040-5940-f9dd-e053-2995a90a0917

Version: 1

Effective Time: 20220817